Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation

• Status: Completed
• Trial end date: 2009-06-01

Summary

The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.

• Phase: Phase 3

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Allergan
• Treatments: Fluoroquinolones; Gatifloxacin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tetrahydrozoline