A Study to Determine if BOL-303224 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. - Full Text View

Sponsor:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00347932

Purpose

Evaluation of the clinical and microbial efficacy of BOL-303224, compared to vehicle in the treatment of bacterial conjunctivitis.

Condition	Intervention	Phase
Acute Bacterial Conjunctivitis	Drug: BOL-303224 Drug: Vehicle	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

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

Primary Outcome Measures:

Clinical Resolution of Bacterial Conjunctivitis [ Time Frame: Day 5 +/- 1 day ] [ Designated as safety issue: No ]
Eradication of Baseline Bacterial Infection [ Time Frame: Day 5 +/- 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	957
Study Start Date:	June 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BOL-303224	Drug: BOL-303224 Subjects with bacterial conjunctivitis were randomized to receive BOL-303224 eye drops TID for 5 days.
2: Placebo Comparator Vehicle of BOL-303224	Drug: Vehicle Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops TID for 5 days.

Eligibility

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

Criteria

Inclusion Criteria:

Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

Pregnant or nursing females.
Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
Use of any antibiotic within 72 hours of treatment.
Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347932

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Laura Trusso

Bausch & Lomb Incorporated

More Information

No publications provided by Bausch & Lomb, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69.

Responsible Party:	Bausch & Lomb, Inc. ( Timothy L Comstock )
Study ID Numbers:	433, BOL-303224
Study First Received:	June 30, 2006
Results First Received:	June 29, 2009
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00347932 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases

Eye Infections
Conjunctivitis
Infection
Conjunctival Diseases

ClinicalTrials.gov processed this record on February 08, 2010