Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis

September 17, 2014 updated by: Bausch & Lomb Incorporated

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

To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb Incorporated

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:

  • Have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent/purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least 1 eye. A minimum score of 1 should be present for both discharge and for bulbar conjunctival injection.
  • Have monocular pin-holed Snellen visual acuity (VA) equal to or better than 20/200 in both eyes. Age appropriate VA testing will be performed. Every effort should be made to obtain a VA measurement in children. If VA is unobtainable in children, it is at the Investigator's discretion to include the subject in the study.
  • Be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

  • Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
  • Have a known hypersensitivity or contraindications to besifloxacin, fluoroquinolones, or any of the ingredients in the study drugs.
  • Be expected to require treatment with systemic or ocular (either eye) nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, or corticosteroids during the study or have used any of these medications within 2 days prior to study start.
  • Be expected to require concurrent ocular therapy in either eye with any ophthalmic solutions (unless specified below), including tear substitutes, during the study or have used any ophthalmic solutions within 2 hours prior to study start. Be expected to require concurrent ocular therapy (either eye) with mast cell stabilizers or decongestants during the study or have used any of the above within 2 days prior to study start.
  • Be expected to require concurrent systemic or ocular therapy with immunosuppressants (eg, Restasis) during the study or have used systemic or ocular immunosuppressants within 30 days prior to study start.
  • Be expected to require treatment with systemic or ocular (either eye) antibacterials (other than study drug) during the study or have used any systemic or ocular antibacterial within 3 days prior to study start.
  • Be likely to require antimicrobial therapy for conditions such as respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media during the study.
  • Have had ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
  • Have suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
  • Have suspected iritis
  • Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
  • Have any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
  • Be immune compromised.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Besifloxacin
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
Other Names:
  • Besivance
PLACEBO_COMPARATOR: Vehicle
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution
Time Frame: Visit 2 (Day 4 or 5)
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Visit 2 (Day 4 or 5)
Microbial Eradication
Time Frame: Visit 2 (Day 4 or 5)
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Visit 2 (Day 4 or 5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution
Time Frame: Visit 3 (Day 6, 7, or 8)
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Visit 3 (Day 6, 7, or 8)
Microbial Eradication
Time Frame: Visit 3 (Day 6, 7, or 8)
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Visit 3 (Day 6, 7, or 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Conjunctival Discharge
Time Frame: At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe
At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Bulbar Conjunctival Injection
Time Frame: At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe
At each follow-up visit (Visit 1, Visit 2 and Visit 3)

Collaborators and Investigators

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

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

February 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (ESTIMATE)

December 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

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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