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Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
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.
Details
| Lead sponsor | Federal University of São Paulo |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 101 |
| Start date | 2009-01 |
| Completion | 2009-06 |
Conditions
- Ocular Infection and Inflammation
Interventions
- 0.3% gatifloxacin and 1.0% prednisolone acetate association
- isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
Primary outcomes
- Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. — Day 15
Countries
Brazil