Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00651586

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 II

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

Resource links provided by NLM:

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Gatifloxacin

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
1: Experimental 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
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

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

2: Active Comparator

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

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, Tamilnadu

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

Additional relevant MeSH terms:

Anti-Infective Agents
Corneal Diseases
Molecular Mechanisms of Pharmacological Action
Fluoroquinolones
Ulcer
Eye Diseases
Eye Infections
Enzyme Inhibitors
Infection

Pharmacologic Actions
Gatifloxacin
Anti-Bacterial Agents
Ciprofloxacin
Pathologic Processes
Therapeutic Uses
Corneal Ulcer
Keratitis
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010