Back to resultsSafety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Primary Purpose
Acute Bacterial Corneal Ulcers, Bacterial Keratitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gatifloxacin 0.3% ophthalmic solution
Ciprofloxacin 0.3% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Corneal Ulcers
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Gatifloxacin 0.3% ophthalmic solution
Ciprofloxacin 0.3% ophthalmic solution
Outcomes
Primary Outcome Measures
Complete re-epithelialization of the corneal ulcer
Secondary Outcome Measures
Investigator's evaluation of clinical efficacy
Patient reported outcomes
Microbiological Cure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651586
Brief Title
Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Corneal Ulcers, Bacterial Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Gatifloxacin 0.3% ophthalmic solution
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ciprofloxacin 0.3% ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Gatifloxacin 0.3% ophthalmic solution
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 0.3% ophthalmic solution
Other Intervention Name(s)
Ciloxan®
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete re-epithelialization of the corneal ulcer
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Investigator's evaluation of clinical efficacy
Time Frame
Day 21
Title
Patient reported outcomes
Time Frame
Day 21
Title
Microbiological Cure
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Galveston
State/Province
Texas
Country
United States
City
Madurai
State/Province
Tamilnadu
Country
India
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
Links:
URL
http://www.allerganclinicaltrials.com
Description
Link to Clinical Trial Results
Learn more about this trial
Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
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