Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Overview
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
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: April 2005
Interventions
- Drug: Gatifloxacin 0.3% ophthalmic solution
- Gatifloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
- Drug: Ciprofloxacin 0.3% ophthalmic solution
- Ciprofloxacin 0.3% ophthalmic solution. On Day 0, one drop instilled in affected eye every 5 minutes for the first 30 minutes, every 30 minutes while awake, and every 2 hours after retiring; on Day 1, one drop instilled in affected eye every hour while awake and 4 hours after retiring; on Days 2 to 6, one drop instilled in affected eye every 2 hours while awake; on Days 7 to 21, one drop instilled in affected eye 4 times daily while awake. Treatment continued through Day 21 (or Day 28 if ulcer had not healed but was improving); dosing terminated when re-epithelialization was complete or on Day 28, whichever occurred sooner
Arms, Groups and Cohorts
- Experimental: 1
- Gatifloxacin 0.3% ophthalmic solution
- Active Comparator: 2
- Ciprofloxacin 0.3% ophthalmic solution
Clinical Trial Outcome Measures
Primary Measures
- Complete re-epithelialization of the corneal ulcer
- Time Frame: Day 21
Secondary Measures
- Investigator’s evaluation of clinical efficacy
- Time Frame: Day 21
- Patient reported outcomes
- Time Frame: Day 21
- Microbiological Cure
- Time Frame: Day 21
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 8 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Allergan
- Provider of Information About this Clinical Study
- Therapeutic Area Head, Allergan, Inc.
- Overall Official(s)
- Medical Director, Study Director, Allergan
References
Prajna V, Vajpayee R, Trocme S, Davitt WF, III, Jensen H, Liu R, Safyan E. Safety and Efficacy of Gatifloxacin 0.3% as Compared With Ciprofloxacin 0.3% for the Treatment of Acute Bacterial Corneal Ulcers. Investigative Ophthalmology & Visual Science. 5-1-2006; 47(5):1916
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