Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).

Detailed Description
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Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin. Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times. Efficacy will be evaluated by change from baseline (Day 0) to Day 63 Â± 3 Days of the global ocular discomfort evaluation (VAS).

Official Title
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Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)

Conditions
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Blepharitis

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Povidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye Exclusion Criteria: Monophtalmia Eyelid dysfunction Facial paralysis. Severe dry eye syndrome. Ocular metaplasia. Filamentous keratitis Schirmer test < 5 mm. Best far corrected visual acuity < 1/10.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Unifluid<br>Eye drops in Single Dose Unit | Drug: Povidone<br>* Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.<br>* Other names: Unifluid;|
| Experimental: Azithromycin<br>Eye drops Single dose unit | Drug: Azithromycin<br>* Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.<br>* Other names: T1225 1.5% - Azyter -;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS - Ranges 0-100 mm) | The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome) | Baseline and D63 (D63 minus baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azyter in patients affected by chronic blepharitis.