A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00348348

Purpose

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

Condition	Intervention	Phase
Acute Bacterial Conjunctivitis	Drug: Besifloxacin Drug: Moxifloxacin solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Clinical Resolution [ Time Frame: Day 5(+/- 1 day) ] [ Designated as safety issue: No ]
Microbial Eradication [ Time Frame: Day 5 (+/- 1 day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Resolution [ Time Frame: Day 8 or Day 9 ] [ Designated as safety issue: No ]
Microbial Eradication [ Time Frame: Day 8 or Day 9 ] [ Designated as safety issue: No ]

Enrollment:	1161
Study Start Date:	June 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Moxifloxacin solution: Active Comparator Moxifloxacin hydrochloride ophthalmic solution 0.5%	Drug: Moxifloxacin solution Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Besifloxacin Suspension: Experimental Besifloxacin hydrochloride ophthalmic suspension 0.6%	Drug: Besifloxacin Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Eligibility

Criteria

Inclusion Criteria:

Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion Criteria:

Pregnant or nursing females.
Use of any antibiotic within 72 hours of enrollment.
Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348348

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Timothy Comstock, OD

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb, Inc. ( Timothy Comstock )
Study ID Numbers:	434
Study First Received:	June 30, 2006
Results First Received:	June 30, 2009
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00348348 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Moxifloxacin

Eye Diseases
Eye Infections
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Moxifloxacin
Therapeutic Uses

Eye Diseases
Eye Infections
Conjunctivitis
Infection
Pharmacologic Actions
Conjunctival Diseases

ClinicalTrials.gov processed this record on September 11, 2009