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

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Ocular Infection and Inflammation
Interventions
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."

Trial Locations (1)

04023-062

Federal University of Sao Paulo - Dept of Ophthalmology, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Federal University of São Paulo

OTHER