Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

Not Applicable

Completed

• Conditions: Inflammation Following Cataract Surgery
• Interventions: Drug: antibiotic/steroid combination; Drug: moxifloxacin / dexamethasone

• Registration Number: NCT00331084
• Lead Sponsor: Federal University of São Paulo

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 postoperative inflammation in patients having cataract surgery

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2006-12
• Study Completion: 2007-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• patients having cataract surgery

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibiotic steroid drops/single vial	antibiotic/steroid combination	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
antibiotic steroids drops	moxifloxacin / dexamethasone	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Primary Outcome Measures

Name	Time	Method
day 15 evaluation of anterior chamber	15 days pos-op

Secondary Outcome Measures

Name	Time	Method
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score	15 days pos-op

Trial Locations

Locations (1)

Dept of Opthalmology - Rua Botucatu 824; 🇧🇷 São Paulo, SP, Brazil