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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00330824 |
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Date of registration:
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26/05/2006 |
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Primary sponsor: |
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Public title:
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Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
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Scientific title:
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Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00330824 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Rubens Belfort Jr, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post Lasik Surgery Inflammation
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Intervention(s)
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Drug: antibiotic/steroid combination
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Drug: moxifloxacin/dexamethasone
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Primary Outcome(s)
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day 15 evaluation of anterior chamber
[Time Frame: 15 days pos-op]
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Secondary Outcome(s)
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day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
[Time Frame: 15 days pos-op]
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Secondary ID(s)
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BRA-05-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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