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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00330824

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

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 :

Apr 1, 2006

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

day 15 evaluation of anterior chamber [15 days pos-op]

Secondary Outcome Measures

day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score [15 days pos-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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