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: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2005

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

• Experimental: 1
  • Gatifloxacin 0.3% ophthalmic solution
• Active Comparator: 2
  • Ciprofloxacin 0.3% ophthalmic solution

Primary Measures

• Complete re-epithelialization of the corneal ulcer
  • Time Frame: Day 21
    Safety Issue?: No

Secondary Measures

• Investigator's evaluation of clinical efficacy
  • Time Frame: Day 21
    Safety Issue?: No
• Patient reported outcomes
  • Time Frame: Day 21
    Safety Issue?: No
• Microbiological Cure
  • Time Frame: Day 21
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651586

Study ID Number: 198782-002

ClinicalTrials.gov Identifier: NCT00651586

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results