Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Information source: Allergan
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Corneal Ulcers; Bacterial Keratitis
Intervention: Gatifloxacin 0.3% ophthalmic solution (Drug); Ciprofloxacin 0.3% ophthalmic solution (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
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
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Complete re-epithelialization of the corneal ulcer
Secondary outcome: Investigator's evaluation of clinical efficacyPatient reported outcomes Microbiological Cure
Eligibility
Minimum age: 8 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Madurai, Tamilnadu, India
Galveston, Texas, United States
Additional Information
Link to Clinical Trial Results
Starting date: October 2003
Ending date: April 2005
Last updated: April 1, 2008
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