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Completed

NCT Number: NCT00972777

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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.

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Key information

Conditions

Bacterial Conjunctivitis Bacterial Infections Bacterial Infections and Mycoses Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Eye Diseases Eye Infections Eye Infections, Bacterial Infections

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Besifloxacin

Drug

Besifloxacin 0.6% administered into the study eye two times a day for three days.

Other names: Besivance

Vehicle (placebo)

Drug

Vehicle administered to the study eye two times a day for three days.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 9, 2009
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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