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Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00972777
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Besifloxacin Drug: Vehicle (Placebo) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Clinical Resolution [ Time Frame: Visit 2 ]
    The absence of both conjunctival discharge and bulbar conjunctival injection.

  2. Microbial Eradication [ Time Frame: Visit 2 ]
    The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.


Secondary Outcome Measures :
  1. Clinical Resolution [ Time Frame: Visit 3 ]
    The absence of both conjunctival discharge and bulbar conjunctival injection.

  2. Microbial Eradication [ Time Frame: Visit 3 ]
    The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972777


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00972777     History of Changes
Other Study ID Numbers: 603
First Posted: September 9, 2009    Key Record Dates
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Besifloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors