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Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00972777
First received: September 4, 2009
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: Besifloxacin
Drug: Vehicle (Placebo)
 Phase 2
Phase 3

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 Besifloxacin Ophthalmic Suspension, 0.6% BID 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 Incorporated:

Primary Outcome Measures:
  • Clinical Resolution [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    The absence of both conjunctival discharge and bulbar conjunctival injection.

  • Microbial Eradication [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.


Secondary Outcome Measures:
  • Clinical Resolution [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
    The absence of both conjunctival discharge and bulbar conjunctival injection.

  • Microbial Eradication [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
    The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.


Enrollment: 474
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besifloxacin
0.6% ophthalmic suspension
 Drug: Besifloxacin
Besifloxacin 0.6% administered into the study eye two times a day for three days.
Other Name: Besivance
Placebo Comparator: Vehicle Drug: Vehicle (Placebo)
Vehicle administered to the study eye two times a day for three days.

  Eligibility

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

Inclusion Criteria:

  • Subjects who are at least one year of age.
  • Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
  • Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
  • Subjects who are expected to require treatment with any disallowed medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972777

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Michael R Paterno, OD Bausch & Lomb Incorporated
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00972777     History of Changes
Other Study ID Numbers: 603
Study First Received: September 4, 2009
Results First Received: January 12, 2012
Last Updated: February 14, 2012
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
 Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013