A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. - Full Text View

Sponsor:	Bausch & Lomb, Inc.
Information provided by (Responsible Party):	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00347932

Purpose

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Condition	Intervention	Phase
Acute Bacterial Conjunctivitis	Drug: ISV-403 Drug: Vehicle	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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: Bacterial Infections Pinkeye

U.S. FDA Resources

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

Primary Outcome Measures:

Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 5 +/- 1 day ] [ Designated as safety issue: No ]
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection [ Time Frame: Day 5 +/- 1 day ] [ Designated as safety issue: No ]
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Secondary Outcome Measures:

Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 8 or 9 ] [ Designated as safety issue: No ]
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection [ Time Frame: Day 8 or 9 ] [ Designated as safety issue: No ]
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

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
Experimental: ISV-403 0.6% ISV-403 ophthalmic suspension	Drug: ISV-403 Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. Other Names: besifloxacin Besivance BOL-303224
Placebo Comparator: Vehicle Vehicle of ISV-403 ophthalmic suspension	Drug: Vehicle Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (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 ClinicalTrials.gov Identifier (NCT Number):

Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85.

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.
ClinicalTrials.gov Identifier:	NCT00347932 History of Changes
Other Study ID Numbers:	433, BOL-303224
Study First Received:	June 30, 2006
Results First Received:	June 29, 2009
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases

Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection

ClinicalTrials.gov processed this record on February 09, 2012