Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Besivance
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
- Subjects who are willing to discontinue contact lens wear for the duration of the study.
- Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Exclusion Criteria:
- Subjects who have any uncontrolled systemic disease or debilitating disease.
- Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
- Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
- Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
- Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
- Subjects with suspected iritis.
- Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
- Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
- Subjects who are immune compromised.
Sites / Locations
- Bausch & Lomb, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Besivance
Vehicle
Arm Description
besifloxacin ophthalmic suspension 0.6%
Vehicle of Besivance
Outcomes
Primary Outcome Measures
Ocular Treatment Emergent Adverse Events
Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Secondary Outcome Measures
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Full Information
NCT ID
NCT01175590
First Posted
August 3, 2010
Last Updated
March 19, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01175590
Brief Title
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Official Title
A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
518 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Besivance
Arm Type
Experimental
Arm Description
besifloxacin ophthalmic suspension 0.6%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of Besivance
Intervention Type
Drug
Intervention Name(s)
Besivance
Intervention Description
Ocular administration to affected eye for 7 days
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle of Besivance administered to affected eye for 7 days
Primary Outcome Measure Information:
Title
Ocular Treatment Emergent Adverse Events
Description
Ocular Treatment-Emergent Adverse Events on the Study Eye
Time Frame
At each visit - 7 days
Title
Non-Ocular Treatment-Emergent Adverse Events
Description
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Clinical Resolution
Description
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Time Frame
Day 8 (Visit 2)
Title
Clinical Resolution
Description
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Time Frame
Day 11 (Visit 3)
Title
Microbial Eradication
Description
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time Frame
Days 8 (Visit 2)
Title
Microbial Eradication
Description
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time Frame
Days 11 (Visit 3)
Title
Microbial Outcome With Clinical Resolution
Description
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time Frame
Day 8 (Visit 2)
Title
Microbial Outcome With Clinical Resolution
Description
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time Frame
Day 11 (Visit 3)
Title
Individual Clinical Outcomes - Ocular Discharge
Description
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame
At day 1 (Vist 1)
Title
Individual Clinical Outcomes - Ocular Discharge
Description
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame
At day 8 (Vist 2)
Title
Individual Clinical Outcomes - Ocular Discharge
Description
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time Frame
At day 11 (Vist 3)
Title
Individual Clinical Outcomes - Bulbar Injection
Description
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame
At day 1 (Vist 1)
Title
Individual Clinical Outcomes - Bulbar Injection
Description
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame
At day 8 (Vist 2)
Title
Individual Clinical Outcomes - Bulbar Injection
Description
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time Frame
At day 11 (Vist 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
Subjects who are willing to discontinue contact lens wear for the duration of the study.
Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Exclusion Criteria:
Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
Subjects with suspected iritis.
Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
Subjects who are immune compromised.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Allaire, MD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
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