Who is sponsoring NCT01603030?

NCT01603030 is sponsored by Adapt Produtos Oftalmológicos Ltda..

What condition does NCT01603030 study?

NCT01603030 studies Eye Infection/Inflammation Other.

What drugs are being tested in NCT01603030?

Interventions: moxifloxacin 0,5% + prednisolone 1%, moxifloxacin/prednisolone combination.

What is the status of NCT01603030?

NCT01603030 is currently UNKNOWN.

Last reviewed 2012-05-21 · How we verify

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 Patients Having Lasik Surgery

NCT01603030 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Adapt Produtos Oftalmológicos Ltda.
Phase	Phase 3
Status	UNKNOWN
Enrolment	66
Start date	2012-06
Completion	2012-09

Conditions

Eye Infection/Inflammation Other

Interventions

moxifloxacin 0,5% + prednisolone 1%
moxifloxacin/prednisolone combination

Primary outcomes

Day 15 Evaluation of Anterior Chamber — 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.

Countries

Brazil