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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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