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Trial registered on ANZCTR


Registration number
ACTRN12613000460707
Ethics application status
Approved
Date submitted
22/04/2013
Date registered
22/04/2013
Date last updated
22/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study: The effect of in-office irrigation with 5% povidone-iodine to reduce the duration of adenoviral conjunctivitis
Scientific title
A Pilot Study: The effect of in-office irrigation with 5% povidone-iodine compared to placebo, at time of adenoviral conjunctivitis diagnosis, on shortening the infectious period of adenoviral conjunctivitis.
Secondary ID [1] 282189 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenoviral conjunctivitis 288700 0
Condition category
Condition code
Eye 289048 289048 0 0
Diseases / disorders of the eye
Infection 289298 289298 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be given 2 tablets of 200mg ibuprofen in office prior to treatment. 2 drops of 0.4% preservative-free oxybuprocaine will be placed in the lower lid of both eyes prior to treatment. This is followed by 5 drops of 5% povidone-iodine in both eyes. 0.9% sterile sodium chloride wil be used to completely irrigate both eyes for 60 seconds after povidone-iodine application.

Preservative-free Blink Intensive tears (active ingredient: polyethylene glycol 0.25%) will be given and the participant will be instructed to place 1 drop in both eyes every 2 hours until the first review the next day, and as required thereafter. Participants will be asked on the frequency of using the drops at follow-up examinations.
Intervention code [1] 286794 0
Treatment: Drugs
Comparator / control treatment
Patients will be given 2 tablet of 200mg ibuprofen in office prior to treatment. 2 drops of 0.4% preservative-free oxybuprocaine will be placed in the lower lid of both eyes prior to treatment. This is followed by 5 drops of 5% fluorescein dye in both eyes. 0.9% sterile sodium chloride wil be used to completely irrigate both eyes for 60 seconds after fluorescein application

Preservative-free Blink Intensive tears will be given and the participant will be instructed to place 1 drop in both eyes every 2 hours until the first review and as required thereafter.
Control group
Placebo

Outcomes
Primary outcome [1] 289161 0
No adenovirus present in the tear film as indicated by the RPS Adeno Detector
Timepoint [1] 289161 0
Day 1, 3, 7, 14, 21 after treatment
Secondary outcome [1] 301946 0
Resolution of adenoviral conjunctivitis clinical signs; including conjunctival redness, follicles and lymph adenopathy. This will be assessed by slit lamp examination or observation by the care provider, and the use of a consistent grading system.
Timepoint [1] 301946 0
Day 1, 3, 7, 14, 21 after treatment
Secondary outcome [2] 301947 0
Resolution of participant symptoms as determined by the "Symptoms Questionnaire"; including irritation, watering and photophobia.
Timepoint [2] 301947 0
Day 1, 3, 7, 14, 21 after treatment

Eligibility
Key inclusion criteria
Patients must have a positive result on the RPS Adeno Detector, plus at least one of the clinical signs of conjunctival redness, follicles or lymph adenopathy; and at least one of the symptoms of irritation, watering or photophobia.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with a history of allergy to anaesthetic eye drops or a known sensitivity to iodine.

Patient who are susceptible to having an adverse reaction to NSAIDs, have a contraindication or are on medications that may interact adversely with ibuprofen. This includes the following:

- An history of allergy to NSAID

- Asthmatic patient

- Gastrointestinal disorders (or history of), including dyspepsia, Crohn’s disease, colitis, gastrointestinal haemorrhage, perforation or ulcer, melaena

- Heart/cardiac impairment (or history of), including cardiac failure, myocardial infarction (heart attack), angina pectoris, stroke

- Liver disorders (or history of), including hepatitis, jaundice and abnormal hepatic function

- Kidney/renal impairment (or history of), including haemutria, interstitial nephritis, renal failure, nephrotic syndrome, proteinuria, renal papillary necrosis

- Pregnant or breastfeeding women

- Hypertension including those on hypertension medication

- Currently taking the following medications: aspirin, diuretics, lithium, hypertensive drugs including ACE inhibitors, beta blockers and diuretics, steroids, zidovudine, probenecid, antidiabetic medication, phenytoin, methotrexate, anticoagulants, SSRIs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting to the University of New South Wales Red Eye clinic diagnosed with adenoviral conjunctivitis will be offered to participate in the study.

Once the patient’s diagnosis of adenoviral conjunctivitis is confirmed, a Participant Information Statement and Consent form will be given for the patient to read through by the student clinician. If consent is given to participate in the study, further eligibility for the study will be determined by questionnaires that will indicate any contraindications the patient may have in participating in the study. There must also be a positive result using the RPS Adeno Detector for the patient to be eligible for the study.

Once deemed eligible for the study, a computer pre-generated randomization table will determine which treatment kit will be used for the patient. Each treatment kit has a unique numerical identifier and has been randomised to contain treatment solution (povidone-iodine) or placebo (fluorescein-saline mix).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-determined table to determine which kit number the patient will be treated with. The kit numbers will be randomised to either '0' or '1' (where '0' indicates treatment group and '1' indicates placebo group) using a computer generated randomization table. This will be carried out by the investigators prior to commencing the study, and will be masked to the clinicians carrying out the treatment and assessing the outcomes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for the study has been calculated with a power of 0.8 and a difference of 7 days in the time of resolution of infection between the treatment and placebo groups. A standard deviation of 4 days is chosen. A p value of <0.05 will be used.

A t-test will be carried out to compare the mean time of recovery between groups, and Fischer’s test will be used to compare resolution of signs and symptoms between placebo and treatment. The Bonferroni correction for multiple corrections will also be employed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6617 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 286953 0
University
Name [1] 286953 0
University of New South Wales,
Country [1] 286953 0
Australia
Primary sponsor type
Individual
Name
Ben Ashby
Address
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 285739 0
Individual
Name [1] 285739 0
Emily Chen
Address [1] 285739 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 285739 0
Australia
Secondary sponsor category [2] 285740 0
Individual
Name [2] 285740 0
Priska Liem
Address [2] 285740 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [2] 285740 0
Australia
Other collaborator category [1] 277337 0
Individual
Name [1] 277337 0
Lily Ho
Address [1] 277337 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 277337 0
Australia
Other collaborator category [2] 277338 0
Individual
Name [2] 277338 0
Maria Bui
Address [2] 277338 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [2] 277338 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289006 0
UNSW HREA Panel D: Biomedical
Ethics committee address [1] 289006 0
Wallace Wurth Blg, Level 5, Rm 513
University of New South Wales
High St, Kensington NSW 2052
Ethics committee country [1] 289006 0
Australia
Date submitted for ethics approval [1] 289006 0
02/04/2013
Approval date [1] 289006 0
10/04/2013
Ethics approval number [1] 289006 0
13094

Summary
Brief summary
The primary purpose of this pilot study aims to determine the effectiveness of treating this particular viral eye infection (adenoviral conjunctivitis) with a one-time in-office irrigation of the eye with 5% povidone-iodine.

We aim to determine whether this treatment reduced the period of infection as well as improving patient’s symptoms'.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38758 0
Miss Priska Liem
Address 38758 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 38758 0
Australia
Phone 38758 0
+612 9385 9879
Fax 38758 0
Email 38758 0
[email protected]
Contact person for public queries
Name 38759 0
Miss Emily Chen
Address 38759 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 38759 0
Australia
Phone 38759 0
+612 9385 9879
Fax 38759 0
Email 38759 0
[email protected]
Contact person for scientific queries
Name 38760 0
Mr Ben Ashby
Address 38760 0
3.023 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 38760 0
Australia
Phone 38760 0
+612 9385 9879
Fax 38760 0
Email 38760 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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