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

Thea Pharma

Status and phase

Completed

Phase 3

Conditions

Conjunctivitis, Bacterial

Treatments

Drug: Azithromycin (T1225)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00357773

LT1225-PIII-11/03

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

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.