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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/NCT03004924
Registration number
NCT03004924
Ethics application status
Date submitted
19/12/2016
Date registered
29/12/2016
Date last updated
9/06/2021
Titles & IDs
Public title
Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine 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 Placebo in the Treatment of Bacterial Conjunctivitis
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Secondary ID [1]
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2016-003361-25
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Secondary ID [2]
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SHP640-303
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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:
Bacterial 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%
Treatment: Drugs - Placebo
Experimental: SHP640 - Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Active Comparator: PVP-I 0.6% - Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
Placebo Comparator: Placebo - Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Treatment: Drugs: SHP640
Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Treatment: Drugs: PVP-I 0.6%
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Treatment: Drugs: Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times 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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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 5
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Assessment method [1]
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Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness 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 [1]
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Day 5
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Secondary outcome [1]
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Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
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Assessment method [1]
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Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. 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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Baseline, Day 5
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Secondary outcome [2]
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Number of Participants With Clinical Resolution
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Assessment method [2]
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Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
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Timepoint [2]
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Day 3, 8 and 12
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Secondary outcome [3]
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Number of Participants With Bacterial Eradication
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Assessment method [3]
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Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
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Timepoint [3]
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Day 3, 8 and 12
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Secondary outcome [4]
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Bulbar Conjunctival Injection Score
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Assessment method [4]
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Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
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Timepoint [4]
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Day 3, 5, 8 and 12
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Secondary outcome [5]
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Change From Baseline in the Bulbar Conjunctival Injection Score
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Assessment method [5]
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Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
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Timepoint [5]
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Baseline, Day 3, 5, 8 and 12
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Secondary outcome [6]
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Ocular Conjunctival Discharge Score
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Assessment method [6]
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Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
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Timepoint [6]
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Day 3, 5, 8 and 12
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Secondary outcome [7]
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Change From Baseline in the Ocular Conjunctival Discharge Score
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Assessment method [7]
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Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
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Timepoint [7]
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Baseline, Day 3, 5, 8 and 12
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Secondary outcome [8]
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Global Clinical Score
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Assessment method [8]
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Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
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Timepoint [8]
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Day 3, 5, 8 and 12
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Secondary outcome [9]
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Change From Baseline in the Global Clinical Score
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Assessment method [9]
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Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
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Timepoint [9]
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Baseline, Day 3, 5, 8 and 12
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Secondary outcome [10]
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Number of Participants With Modified Clinical Resolution
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Assessment method [10]
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Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
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Timepoint [10]
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Day 3, 5, 8 and 12
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Secondary outcome [11]
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Number of Participants With Expanded Clinical Resolution
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Assessment method [11]
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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 defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
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Timepoint [11]
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Day 3, 5, 8 and 12
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Secondary outcome [12]
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Time to Clinical Resolution
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Assessment method [12]
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Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
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Timepoint [12]
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Baseline to Day 12
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Secondary outcome [13]
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Number of Participants Who Used Rescue Medication
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Assessment method [13]
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Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
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Timepoint [13]
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Baseline to Day 12
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Secondary outcome [14]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [14]
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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. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
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Timepoint [14]
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From start of study drug administration up to 14 days
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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 less than (<) 3 months of age
at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37
weeks gestational age at birth).
- Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
- Have a clinical diagnosis of suspected bacterial 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 bacterial conjunctivitis for less
than or equal to (<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar
Conjunctival Injection Scale
3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular
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 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 participant 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 preplanned overnight hospitalization during the period of the study.
- Have presence of any intraocular, corneal, or conjunctival ocular inflammation
(example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis),
other than bacterial conjunctivitis.
- Have active or a 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-bacterial ocular infection (eg,
viral, 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 (ie, 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 (ie, 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 (eg, 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 that requires
invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor
inhibitors or corticosteroids) and may progress during the study participation period.
- Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.
- Have used any topical ocular non-steroidal anti-inflammatory drugs 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 periocular 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 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 (anti-hepatitis 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
Completed
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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
29/03/2017
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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
1/10/2018
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Sample size
Target
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Accrual to date
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Final
753
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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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Colorado
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Israel
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Israel
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Petah Tikva
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Olsztyn
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Poland
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State/province [55]
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Tarnów
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Country [56]
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Poland
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State/province [56]
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Warszawa
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Country [57]
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Puerto Rico
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State/province [57]
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Arecibo
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Country [58]
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Puerto Rico
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State/province [58]
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Carolina
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Country [59]
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Puerto Rico
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State/province [59]
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San Juan
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Country [60]
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South Africa
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State/province [60]
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Gauteng
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Country [61]
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Spain
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State/province [61]
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Asturias
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Country [62]
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Spain
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State/province [62]
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Huelva
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Country [63]
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Spain
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State/province [63]
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Madrid
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Country [64]
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Spain
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State/province [64]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Ethics approval
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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 bacterial
conjunctivitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03004924
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03004924
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