Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
NCT ID: NCT00330824
Last Updated: 2009-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2006-04-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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antibiotic steroid (single vial)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
antibiotic/steroid combination
1gtt, 4x/d, 15 days
antibiotic / steroid (2 vials)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
moxifloxacin/dexamethasone
1gtt, 4x/days, 15 days
Interventions
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antibiotic/steroid combination
1gtt, 4x/d, 15 days
moxifloxacin/dexamethasone
1gtt, 4x/days, 15 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Head Professor of Ophthalmology
Principal Investigators
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Rubens Belfort Jr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Dept. of Ophthalmology - Rua Botucatu 824
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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BRA-05-02
Identifier Type: -
Identifier Source: org_study_id
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