Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis

Study Overview
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Brief Summary
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To demonstrate the efficacy of T1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

Detailed Description
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The aim of the present study was to compare the efficacy and safety of T1225 1.5% eye drops administered BID for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. The study was conducted as a Phase III, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.

Official Title
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Clinical Efficacy and Safety of T1225 1.5% Eye Drops (3-Day Treatment) Versus Tobramycin 0.3 % Eye Drops (7-Day Treatment) in the Treatment of Purulent Bacterial Conjunctivitis

Conditions
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Conjunctivitis, Bacterial

Intervention / Treatment
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* Drug: Azithromycin (T1225)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female >= 1 day old (newborn, infant, child, adult); written informed consent by patient or legally acceptable representative; purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) AND conjunctival purulent discharge (mild, moderate or severe). Exclusion Criteria: Bacterial conjunctivitis diagnosed >= 7 days ago; bacterial infection due to trauma or foreign body; dacryocystitis; corneal ulceration or keratitis; viral ocular infection; closed angle glaucoma; acute allergy conjunctivitis; clinically significant ocular abnormality; organic amblyopia, monophthalmia; corrected visual acuity below 20/100; contact lens wearer; newborn (i.e. 0-2 months old) not born at term (< 37 weeks of amenorrhea); ocular surgery, laser in situ keratomileusis (LASIK), laser epithelial keratomileusis (LASEK), or photo-refractive keratectomy (PRK) in last 12 months; ocular laser treatment in last 3 months; systemic macrolide antibiotics in last month; systemic steroids in last 2 weeks or during the study; topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) in last week; topical (ocular, nasal, bronchial etc.) treatments and/or systemic NSAIDs in last day; immunosuppressives and/or any systemic antibiotic on D0.

Ages Eligible for Study
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Minimum Age: 1 Day

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin (T1225)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure in the worse eye on Test of Cure (TOC) visit at Day 9, defined as a score 0 for bulbar conjunctival injection and a score 0 for conjunctival purulent discharge (each graded on 4-point scales) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure at Day 3 |  |  | 
| Microbiological cure at Day 3 and Day 9 |  |  | 
| Global efficacy. |  |  | 
| Tolerance |  |  |