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

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Gatifloxacin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, 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 ]

Estimated Enrollment:	450
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Allergan Inc

Locations

United States, California
	Recruiting
Downey, California, United States
India, Bangalore
	Recruiting
Rajajinagar, Bangalore, India

Sponsors and Collaborators

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	198782-005
Study First Received:	August 16, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00518089
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 15, 2009