A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00464438

Purpose

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: gatifloxacin Drug: moxifloxacin 0.5% eye drops	Phase IV

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline Tetrahydrozoline hydrochloride Gatifloxacin

U.S. FDA Resources

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

Further study details as provided by Allergan:

Primary Outcome Measures:

Clearing of conjunctival erythemea and conjunctival discharge [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological improvement [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Improvement in ocular signs [ Time Frame: Days 7 ] [ Designated as safety issue: No ]

Enrollment:	171
Study Start Date:	June 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: gatifloxacin Day 1-6 = 1 drop of study medication three times a day
2: Active Comparator	Drug: gatifloxacin Day 1-6 = 1 drop of study medication three times a day Drug: moxifloxacin 0.5% eye drops Day 1-6 = 1 drop of study medication three times a day

Eligibility

Ages Eligible for Study:	up to 31 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosed with bacterial conjunctivitis

Exclusion Criteria:

chemical or foreign body trauma to either eye
infection in either eye (besides bacterial conjunctivitis)
white spots in the cornea or ulcers in either eye
clinical diagnosis of chlamydia or gonorrhea in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464438

Locations

United States, California

Sacramento, California, United States
Canada, Ontario

Whitby, Ontario, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	198782-003
Study First Received:	April 19, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00464438
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Moxifloxacin
Eye Diseases

Eye Infections
Tetrahydrozoline
Conjunctivitis
Conjunctival Diseases
Gatifloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009