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

Tracking Information

First Received Date ^ICMJE

August 16, 2007

Last Updated Date

September 16, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Clearing of conjunctival hyperemia and conjunctival discharge on Day 6

Change History

Complete list of historical versions of study NCT00518089 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Microbiological cure, clinical improvement of ocular signs, clinical improvement of ocular symptoms

Descriptive Information

Brief Title ^ICMJE

A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Bacterial Conjunctivitis

Intervention ^ICMJE

Drug: Gatifloxacin 0.5% eye drops
Drug: placebo eye drops

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

859

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, India

Administrative Information

NCT ID ^ICMJE

NCT00518089

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

198782-005

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP