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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02998541
Registration number
NCT02998541
Ethics application status
Date submitted
16/12/2016
Date registered
20/12/2016
Date last updated
14/06/2021
Titles & IDs
Public title
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
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Scientific title
A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
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Secondary ID [1]
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2016-002439-14
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Secondary ID [2]
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SHP640-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adenoviral Conjunctivitis
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Condition category
Condition code
Infection
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Other infectious diseases
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Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SHP640
Treatment: Drugs - PVP-I 0.6%
Other interventions - Placebo
Experimental: SHP640 - Participants will receive one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Active Comparator: PVP-I 0.6% - Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.
Placebo Comparator: Placebo - Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days.
Treatment: Drugs: SHP640
Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Treatment: Drugs: PVP-I 0.6%
Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Other interventions: Placebo
Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6
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Assessment method [1]
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Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
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Timepoint [1]
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Day 6
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Secondary outcome [1]
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Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
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Assessment method [1]
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Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
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Timepoint [1]
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Day 6
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Secondary outcome [2]
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Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6
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Assessment method [2]
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Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
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Timepoint [2]
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Day 6
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Secondary outcome [3]
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Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3
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Assessment method [3]
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Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.
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Timepoint [3]
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Day 3
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Secondary outcome [4]
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Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6
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Assessment method [4]
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Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
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Timepoint [4]
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Day 6
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Secondary outcome [5]
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Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6
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Assessment method [5]
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Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.
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Timepoint [5]
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Day 6
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Secondary outcome [6]
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Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8
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Assessment method [6]
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qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.
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Timepoint [6]
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Day 6 and 8
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Secondary outcome [7]
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Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)
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Assessment method [7]
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Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
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Timepoint [7]
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Day 8 and 12/ET
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Secondary outcome [8]
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Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)
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Assessment method [8]
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Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores.
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Timepoint [8]
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Day 3, 8 and 12/ET
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Secondary outcome [9]
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Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [9]
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The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.
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Timepoint [9]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [10]
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Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [10]
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Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
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Timepoint [10]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [11]
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Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [11]
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Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
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Timepoint [11]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [12]
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Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [12]
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Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.
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Timepoint [12]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [13]
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Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [13]
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Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.
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Timepoint [13]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [14]
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Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
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Assessment method [14]
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Time to clinical resolution were reported based on the assessments in the study eye.
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Timepoint [14]
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Day 3, 6, 8 and 12/ET
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Secondary outcome [15]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640
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Assessment method [15]
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An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.
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Timepoint [15]
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From start of the study up to Day 14
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Eligibility
Key inclusion criteria
- An understanding, ability, and willingness to fully comply with study procedures and
restrictions (by the parent(s), guardian, or legally authorized representative, if
applicable).
- Ability to voluntarily provide written, signed, and dated (personally or via a
parent(s), guardian, or legally authorized representative(s) informed consent (and
assent, if applicable) to participate in the study.
- Participants of any age at Visit 1 (Note: participants lesser than (<) 3 months of age
at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks
gestational age at birth).
- Meet at least 1 of the 2 criteria below:
a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of
the following 5 criteria, based upon medical history and examination: i.Symptoms
within the past 7 days consistent with acute upper respiratory tract infection (eg.
sore throat, cough, rhinorrhea, etc).
ii. Contact within the past 7 days with family members or other individuals with recent
onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of
one or more of the following ocular symptoms: burning/irritation, foreign body sensation,
light sensitivity.
iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva.
Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at
least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.
- Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye
confirmed by the presence of the following minimal clinical signs and symptoms in that
same eye:
1. Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesser
than or equal to (<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar
Conjunctival Injection Scale.
3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery
Conjunctival Discharge Scale
- Be willing to discontinue contact lens wear for the duration of the study.
- Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as
measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will
be assessed by an age appropriate method in accordance with the AAP Policy Statement
for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians
(Donahue and Baker 2016; American Academy of Pediatrics 2016).The policy statement
recommends formal vision screening can begin at 3 years of age. VA measurements for
children under the age of 3 will be done at the discretion of the investigator.
- If not done, child should be able to fixate on and follow a moving object, except
participants <2 months of age who have not yet developed this ability. Participants <2
months will be enrolled at the discretion of the investigator.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable
contraceptive requirements of the protocol or females of non-childbearing potential.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current or recurrent disease that could affect the action, absorption, or disposition
of the investigational product, or clinical or laboratory assessments, per
investigator's discretion.
- Current or relevant history of physical or psychiatric illness, any medical disorder
that may make the participants unlikely to fully complete the study, or any condition
that presents undue risk from the investigational product or procedures.
- Have known or suspected intolerance or hypersensitivity to the investigational
product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in a FST-100 or SHP640 clinical study.
- Participants who are employees, or immediate family members of employees (who are
directly related to study conduct), at the investigational site.
- Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or
planned for the period of the study.
- Have a pre-planned overnight hospitalization during the period of the study.
- Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg,
uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than
adenoviral conjunctivitis.
- Have presence of corneal subepithelial infiltrates at Visit 1.
- Have active or history of ocular herpes.
- Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more
consistent with the diagnosis of non-infectious conjunctivitis (except presumed
seasonal/perennial allergic conjunctivitis), or non-adenoviral ocular infection (e.g.
bacterial, fungal, acanthamoebal, or other parasitic).
Note:history or concomitant presence of presumed seasonal or perennial allergic
conjunctivitis signs/symptoms is not exclusionary.
- Neonates or infants (i.e. participants less than 12 months of age) who have suspected
or confirmed (based on the result of any test conducted prior to screening)
conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
- Neonates or infants (i.e. participants less than 12 months of age) whose birth mothers
had any sexually transmitted disease within 1 month of delivery or any history of
genital herpes.
- Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
- Presence of any significant ophthalmic condition (e.g. Retinopathy of Prematurity,
congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic
involvement that could affect study variables.
- Be a known intraocular pressure (IOP) steroid responder, have a known history or
current diagnosis of glaucoma, or be a glaucoma suspect.
- Have any known clinically significant optic nerve defects.
- Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary
to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect
or any significant corneal opacity at Visit 1.
- Presence of significant, active condition in the posterior segment which requires
invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or
corticosteroids) and may progress during the study participation period.
- Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days of
enrollment.
- Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) within <=
1 day of enrollment.
- Have used any topical ophthalmic steroids in the last <= 14 days.
- Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable
(initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is
allowed, given no anticipated change in dose for the duration of the study. Topical
dermal steroids are allowed except in the peri-ocular area.
- Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
- Have used any topical ophthalmic products, including tear substitutes, and
over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be
unable to discontinue all topical ophthalmic products for the duration of the study.
Use of hot or cold compresses is also not permitted during the study.
- Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled
systemic disease or debilitating disease (eg, cardiovascular disease, hypertension,
sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may
affect the study parameters, per the investigator's discretion.
- Any known history of immunodeficiency disorder or known active conditions predisposing
to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence
of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone
marrow transplantation.
- Within 30 days prior to the first dose of investigational product:
1. Have used an investigational product or device, or
2. Have been enrolled in a clinical study (including vaccine studies) that, in the
investigator's opinion, may impact this Shire-sponsored study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/05/2019
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Sample size
Target
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Accrual to date
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Final
219
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of the Sunshine Coast Clinical Trials Centre - Sippy Downs
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Recruitment postcode(s) [1]
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4556 - Sippy Downs
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Nevada
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Austria
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Linz
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Vienna
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Ontario
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Haute Vienne
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France
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Paris
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Mainz
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Germany
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Muenster
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Hungary
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Csongrad
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Hungary
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Heves
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Debrecen
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Kaposvár
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Hungary
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Veszprem
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India
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West Bengal
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Israel
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Afula
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Israel
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Beer Sheva
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Israel
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Haifa
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Bologna
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Peru
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La Libertad
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Peru
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Lima
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Poland
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Bytom
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Tarnów
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Poland
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Warszawa
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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Spain
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Asturias
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Burgos
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Girona
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Spain
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Huelva
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Sevilla
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Valencia
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Spain
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Zaragoza
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United Kingdom
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Greater Manchester
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Funding & Sponsors
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Commercial sector/Industry
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Name
Shire
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Summary
Brief summary
The purpose of this study is to determine if an investigational treatment is effective
compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral
conjunctivitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02998541
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Contacts
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Study Director
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02998541
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