Status:
COMPLETED
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Allergan
Conditions:
Ocular Infection and Inflammation
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01218737
Start Date
January 1 2009
End Date
June 1 2009
Last Update
March 21 2018
Active Locations (1)
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1
Federal University of Sao Paulo - Dept of Ophthalmology
São Paulo, São Paulo, Brazil, 04023-062