NCT01218737

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ocular Infection and Inflammation

Interventions

Type	Name	Description
DRUG	0.3% gatifloxacin and 1.0% prednisolone acetate association	Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
DRUG	isolated 0.3% gatifloxacin and 1.0% prednisolone acetate	Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2010-10-11
• Last updated: 2018-03-21

Locations

1 site across 1 country: Brazil