A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00518089

Purpose

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: Gatifloxacin 0.5% eye drops Drug: placebo eye drops	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Tetrahydrozoline Gatifloxacin Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Proportion of patients with clearing of conjunctival hyperemia and conjunctival discharge [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological cure [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Clinical improvement of ocular signs [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Clinical improvement of ocular symptoms [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Enrollment:	859
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Gatifloxacin 0.5% eye drops Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
2: Placebo Comparator	Drug: placebo eye drops Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

Signs and/or symptoms of conjunctivitis for more than 96 hours
Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
Clinical diagnosis of chlamydia in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518089

Locations

United States, California

Downey, California, United States
India, Bangalore

Rajajinagar, Bangalore, India

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	198782-005
Study First Received:	August 16, 2007
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00518089 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Pseudoephedrine
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Cardiovascular Agents
Conjunctivitis
Tetrahydrozoline

Conjunctival Diseases
Nasal Decongestants
Gatifloxacin
Oxymetazoline
Phenylephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Respiratory System Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Sympathomimetics
Eye Diseases
Physiological Effects of Drugs
Eye Infections
Cardiovascular Agents
Conjunctivitis

Tetrahydrozoline
Infection
Pharmacologic Actions
Conjunctival Diseases
Nasal Decongestants
Gatifloxacin
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009