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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Azithromycin; Tobramycin

Criteria

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.