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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ocular Infection and Inflammation

Intervention / Treatment
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* Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association
* Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Association<br>0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo | Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association<br>* 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.<br>* Other names: Zypred;|
| Active Comparator: Isolated ingredients<br>0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations | Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate<br>* 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.<br>* Other names: Pred Fort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. |  | Day 15 |