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:	NCT00509873

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

Drug Information available for: 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:

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:

578

Study Start Date:

August 2007

Study Completion Date:

June 2008

Primary Completion Date:

June 2008 (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: NCT00509873

Locations

United States, Louisiana

Gretna, Louisiana, United States

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:

198782-004

First Received:

July 30, 2007

Last Updated:

December 17, 2008

ClinicalTrials.gov Identifier:

NCT00509873

Health Authority:

United States: Food and Drug Administration

Study placed in the following topic categories:

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

Conjunctival Diseases
Gatifloxacin
Naphazoline
Oxymetazoline
Guaifenesin
Phenylephrine
Ephedrine
Phenylpropanolamine

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Autonomic Agents
Sympathomimetics
Therapeutic Uses
Physiological Effects of Drugs

Vasoconstrictor Agents
Cardiovascular Agents
Peripheral Nervous System Agents
Infection
Pharmacologic Actions
Nasal Decongestants

ClinicalTrials.gov processed this record on January 07, 2009