Overview

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