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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