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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Infection and Inflammation
• Intervention / Treatment: Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association; Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023-062
      • Federal University of Sao Paulo - Dept of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Association; 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo	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.; Other Names: Zypred
ACTIVE_COMPARATOR: Isolated ingredients; 0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations	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.; Other Names: Zymar; Pred Fort

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Allergan

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (ESTIMATE): October 11, 2010

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Inflammation; Infections; Communicable Diseases; Eye Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Gatifloxacin
• Other Study ID Numbers: AG9890X-001