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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330824
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : August 7, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
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Brief Summary:
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

Condition or disease Intervention/treatment Phase
Post Lasik Surgery Inflammation Drug: antibiotic/steroid combination Drug: moxifloxacin/dexamethasone Not Applicable

Detailed Description:
antibiotic/steroid combination compared to individuals components 15 days of treatment
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery
Study Start Date : April 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: antibiotic steroid (single vial)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
 Drug: antibiotic/steroid combination
1gtt, 4x/d, 15 days
Other Name: moxifloxacin/dexamethasone
Active Comparator: antibiotic / steroid (2 vials)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
 Drug: moxifloxacin/dexamethasone
1gtt, 4x/days, 15 days
Other Name: moxifloxacin / dexamethasone


Outcome Measures
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Primary Outcome Measures :
  1. day 15 evaluation of anterior chamber [ Time Frame: 15 days pos-op ]

Secondary Outcome Measures :
  1. day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score [ Time Frame: 15 days pos-op ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330824


Locations
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Brazil
Dept. of Ophthalmology - Rua Botucatu 824
São paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Rubens Belfort Jr, MD, PhD Federal University of São Paulo
More Information
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Responsible Party: Rubens Belfort Jr, Head Professor of Ophthalmology
ClinicalTrials.gov Identifier: NCT00330824    
Other Study ID Numbers: BRA-05-02
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009
Keywords provided by Federal University of São Paulo:
prevention of post inflammation in LASIK surgery
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Anti-Bacterial Agents
Moxifloxacin
Dexamethasone
Dexamethasone acetate
Norgestimate, ethinyl estradiol drug combination
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents