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

March 4, 2015 updated by: Bausch & Lomb Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1161

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Moxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Drug: Moxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
EXPERIMENTAL: Besifloxacin Suspension
Besifloxacin hydrochloride ophthalmic suspension 0.6%
Drug: Besifloxacin
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution
Time Frame: Day 5(+/- 1 day)
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Day 5(+/- 1 day)
Microbial Eradication
Time Frame: Day 5 (+/- 1 day)
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Day 5 (+/- 1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 8 or Day 9
Microbial Eradication
Time Frame: Day 8 or Day 9
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Day 8 or Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (ESTIMATE)

July 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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