Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection and Inflammation After Refractive Surgery (Lasik).
Intervention: 0.3% gatifloxacin and 1.0% prednisolone acetate association (Drug); isolated 0.3% gatifloxacin and 1.0% prednisolone acetate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Federal University of Sao Paulo - Dept of Ophthalmology, Sao Paulo, SP 04023-062, Brazil
Additional Information
Starting date: January 2009
Last updated: October 14, 2010
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