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Completed

NCT Number: NCT00348348

A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.

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Key information

Conditions

Acute Bacterial Conjunctivitis

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

Exclusion criteria

  • Pregnant or nursing females.
  • Use of any antibiotic within 72 hours of enrollment.
  • Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug.
  • Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.

Treatment and study plan

Besifloxacin

Drug

Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

Moxifloxacin solution

Drug

Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.

Primary outcomes

  1. Clinical Resolution

    Time frame: Day 5(+/- 1 day)

    Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)

  2. Microbial Eradication

    Time frame: Day 5 (+/- 1 day)

    eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated

Secondary outcomes

  1. Clinical Resolution

    Time frame: Day 8 or Day 9

    Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated

  2. Microbial Eradication

    Time frame: Day 8 or Day 9

    Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
Mar 24, 2015

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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