Ocular Infection and Inflammation
Conditions
Brief 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.
Interventions
DRUG0.3% 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.
DRUGisolated 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.
Sponsors
Allergan
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method. * Patient presents a normal eye fundus. * Patient has intraocular pressure (IOP) ≤ 20 mmHg.
Exclusion criteria
* Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.). * Patient has diabetes or is immunodepressed. * Any systemic infection during the study. * Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology). * Have used any systemic or topical antibiotics for ocular infection in the previous 14 days. * Patient has known hypersensitivity to any of the components of the formulations used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. | Day 15 |
Countries
Brazil
Outcome results
None listed