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Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00651586
First received: April 1, 2008
Last updated: July 25, 2008
Last verified: July 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Bacterial Corneal Ulcers
Bacterial Keratitis
 Drug: Gatifloxacin 0.3% ophthalmic solution
Drug: Ciprofloxacin 0.3% ophthalmic solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Complete re-epithelialization of the corneal ulcer [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's evaluation of clinical efficacy [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Microbiological Cure [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: October 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gatifloxacin 0.3% ophthalmic solution
 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
Active Comparator: 2
Ciprofloxacin 0.3% ophthalmic solution
 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
Other Name: Ciloxan®

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651586

Locations
United States, Texas
Galveston, Texas, United States
India
Madurai, Tamilnadu, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Link to Clinical Trial Results  This link exits the ClinicalTrials.gov site

Publications:
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

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00651586     History of Changes
Other Study ID Numbers: 198782-002
Study First Received: April 1, 2008
Last Updated: July 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Corneal Ulcer
Keratitis
Ulcer
Eye Infections
Infection
Corneal Diseases
Eye Diseases
Pathologic Processes
Ciprofloxacin
 Fluoroquinolones
Gatifloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013