Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis
Phase 3
Completed
- Conditions
- Conjunctivitis, Bacterial
- Registration Number
- NCT00357773
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Clinical cure at Day 3 Microbiological cure at Day 3 and Day 9 Global efficacy. Tolerance