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

Post Lasik Surgery Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330824
• Other study ID #: BRA-05-02
• Status: Completed
• Phase: N/A
• First received: May 26, 2006
• Last updated: August 6, 2009
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: August 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Post Lasik Surgery Inflammation

Intervention

Drug:
• antibiotic/steroid combination
1gtt, 4x/d, 15 days
• moxifloxacin/dexamethasone
1gtt, 4x/days, 15 days

Locations

Country	Name	City	State
Brazil	Dept. of Ophthalmology - Rua Botucatu 824	São paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	day 15 evaluation of anterior chamber		15 days pos-op	Yes
Secondary	day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score		15 days pos-op	Yes