Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

Not Applicable

Completed

• Conditions: Post Lasik Surgery Inflammation
• Interventions: Drug: antibiotic/steroid combination; Drug: moxifloxacin/dexamethasone

• Registration Number: NCT00330824
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

Detailed Description

antibiotic/steroid combination compared to individuals components 15 days of treatment

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• patients having LASIK surgery;
• men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems

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 (single vial)	antibiotic/steroid combination	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
antibiotic / steroid (2 vials)	moxifloxacin/dexamethasone	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK 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 Ophthalmology - Rua Botucatu 824; 🇧🇷 São paulo, SP, Brazil