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

Federal University of São Paulo

Status: Completed

Conditions: Post Lasik Surgery Inflammation

Treatments: Drug: moxifloxacin/dexamethasone; Drug: antibiotic/steroid combination

Study type: Interventional

Funder types: Other

Identifiers

NCT00330824

BRA-05-02

Details and patient eligibility

About

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

Full description

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

antibiotic steroid (single vial)

Experimental group

Description:

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery

Treatment:

Drug: antibiotic/steroid combination

antibiotic / steroid (2 vials)

Active Comparator group

Description:

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery

Treatment:

Drug: moxifloxacin/dexamethasone