Conjunctivitis, Bacterial Clinical Trial
Official title:
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
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
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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