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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Gatifloxacin
Fluoroquinolones
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014