A Study to Determine if 0.6% ISV-403 is Safe and Effective 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 Vehicle in the Treatment of Bacterial Conjunctivitis.

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

957

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
  • Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
  • Use of any antibiotic within 72 hours of treatment.
  • Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
  • Participation in an ophthalmic drug or device research study within 30 days prior to entry into the 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISV-403
0.6% ISV-403 ophthalmic suspension
Drug: ISV-403
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
Other Names:
  • Besivance
  • besifloxacin
  • BOL-303224
Placebo Comparator: Vehicle
Vehicle of ISV-403 ophthalmic suspension
Drug: Vehicle
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution of Baseline Bacterial Conjunctivitis
Time Frame: Day 5 +/- 1 day
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Day 5 +/- 1 day
Microbial Eradication of Baseline Bacterial Infection
Time Frame: Day 5 +/- 1 day
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Day 5 +/- 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution of Baseline Bacterial Conjunctivitis
Time Frame: Day 8 or 9
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Day 8 or 9
Microbial Eradication of Baseline Bacterial Infection
Time Frame: Day 8 or 9
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Day 8 or 9

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Laura Trusso, 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)

November 1, 2007

Study Completion (Actual)

November 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

  • 433
  • BOL-303224 (Registry Identifier: CAS)

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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