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

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Ocular Infection and Inflammation

Treatments: Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association; Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01218737

AG9890X-001

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

101 participants in 2 patient groups

Association

Experimental group

Description:

0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo

Treatment:

Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association

Isolated ingredients

Active Comparator group

Description:

0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations

Treatment:

Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate