Clinical Trial: Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Pat

Brief Summary: This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK surgery.

Detailed Summary: antibiotic/steroid combination compared to individuals components 15 days of treatment
Sponsor: Adapt Produtos Oftalmológicos Ltda.

Current Primary Outcome: Day 15 Evaluation of Anterior Chamber [ Time Frame: 15 days ]

The primary efficacy variable of this study is the percentage of patients with a score of zero postoperative inflammation (anterior chamber inflammation, ie, presence of cells in the anterior chamber (0-4) in the study on Day 15. The absence of bacterial infection on Day 15 ± 1 will be assumed to demonstrate that the antibacterial agents in the association of moxifloxacin / acetate Prednisolona1% and moxifloxacin + acetate Prednisolona1% Eye drops are equal in antimicrobial effectiveness, and that they acted in a prophylactic manner to prevent of bacterial infection.


Original Primary Outcome: Same as current

Current Secondary Outcome: day 15 physician´s follow-up impression of inflammatory reaction score [ Time Frame: 15 days ]

the clinical evaluation will be based on the following variables: IOP, assessment of visual acuity, slit lamp examination (lids, conjunctiva, cornea), and examination of the fundus (retina / macula / choroid, vitreous and optic nerve).


Original Secondary Outcome: Same as current

Information By: Adapt Produtos Oftalmológicos Ltda.

Dates:
Date Received: March 22, 2011
Date Started: June 2012
Date Completion: September 2012
Last Updated: May 21, 2012
Last Verified: May 2012