Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers

Phase 2

Completed

• Conditions: Acute Bacterial Corneal Ulcers; Bacterial Keratitis
• Interventions: Drug: Ciprofloxacin 0.3% ophthalmic solution; Drug: Gatifloxacin 0.3% ophthalmic solution

• Registration Number: NCT00651586
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the safety and efficacy of gatifloxacin 0.3% ophthalmic solution compared with ciprofloxacin 0.3% ophthalmic solution in patients with acute bacterial corneal ulcers

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-03
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-25
• Last Update Posted: 2008-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Clinical diagnosis in one eye only of an acute bacterial corneal ulcer (>1mm)

Exclusion Criteria

• Corneal ulcer that in the opinion of the investigator had to be treated with fortified antibiotics, or multiple antibiotics, or anti-infectives other than study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ciprofloxacin 0.3% ophthalmic solution	Ciprofloxacin 0.3% ophthalmic solution
1	Gatifloxacin 0.3% ophthalmic solution	Gatifloxacin 0.3% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Complete re-epithelialization of the corneal ulcer	Day 21

Secondary Outcome Measures

Name	Time	Method
Microbiological Cure	Day 21
Patient reported outcomes	Day 21
Investigator's evaluation of clinical efficacy	Day 21