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Completed

NCT Number: NCT01218737

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

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.

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Key information

Conditions

Ocular Infection and Inflammation Eye Diseases Eye Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Sao Paulo - Dept of Ophthalmology

São Paulo, 04023-062, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.3% gatifloxacin and 1.0% prednisolone acetate association

Drug

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

isolated 0.3% gatifloxacin and 1.0% prednisolone acetate

Drug

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

Primary outcomes

  1. Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.

    Time frame: Day 15

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 11, 2010
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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