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

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.

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.