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

Phase 3

Completed

• Conditions: Ocular Infection and Inflammation
• Interventions: Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association; Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate

• Registration Number: NCT01218737
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Association	0.3% gatifloxacin and 1.0% prednisolone acetate association	0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo
Isolated ingredients	isolated 0.3% gatifloxacin and 1.0% prednisolone acetate	0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations

Primary Outcome Measures

Name	Time	Method
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.	Day 15

Trial Locations

Locations (1)

Federal University of Sao Paulo - Dept of Ophthalmology; 🇧🇷 Sao Paulo, SP, Brazil