Status:
COMPLETED
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery
Lead Sponsor:
Federal University of São Paulo
Conditions:
Inflammation Following Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Detailed Description
Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperati...
Eligibility Criteria
Inclusion
- patients having cataract surgery
Exclusion
- Uncontrolled glaucoma or intraocular hypertension;
- Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
- A history of chronic or recurrent ocular inflammatory disease;
- Uncontrolled diabetes mellitus and diabetic retinopathy ;
- Patients with sight in a single eye;
- Iris atrophy in the eye to be operated;
- Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
- Known or suspected allergy or hypersensitivity to any component of study medication;
- A history or any other evidence of severe systemic disease
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00331084
Start Date
April 1 2006
End Date
March 1 2007
Last Update
August 7 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept of Opthalmology - Rua Botucatu 824
São Paulo, São Paulo, Brazil, 04023-062