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

August 6, 2009 updated by: Federal University of São Paulo

Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São paulo, SP, Brazil, 04023-062
        • Dept. of Ophthalmology - Rua Botucatu 824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • moxifloxacin / dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
day 15 evaluation of anterior chamber
Time Frame: 15 days pos-op
15 days pos-op

Secondary Outcome Measures

Outcome Measure
Time Frame
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
Time Frame: 15 days pos-op
15 days pos-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

May 26, 2006

First Submitted That Met QC Criteria

May 26, 2006

First Posted (ESTIMATE)

May 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRA-05-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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