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Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Besifloxacin
Vehicle (Placebo)
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who are at least one year of age.
  • Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
  • Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
  • Subjects who are expected to require treatment with any disallowed medications.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Besifloxacin

Vehicle

Arm Description

0.6% ophthalmic suspension

Outcomes

Primary Outcome Measures

Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Secondary Outcome Measures

Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Full Information

First Posted
September 4, 2009
Last Updated
February 14, 2012
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00972777
Brief Title
Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2011 (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
This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Besifloxacin
Arm Type
Experimental
Arm Description
0.6% ophthalmic suspension
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Besifloxacin
Other Intervention Name(s)
Besivance
Intervention Description
Besifloxacin 0.6% administered into the study eye two times a day for three days.
Intervention Type
Drug
Intervention Name(s)
Vehicle (Placebo)
Intervention Description
Vehicle administered to the study eye two times a day for three days.
Primary Outcome Measure Information:
Title
Clinical Resolution
Description
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame
Visit 2
Title
Microbial Eradication
Description
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame
Visit 2
Secondary Outcome Measure Information:
Title
Clinical Resolution
Description
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time Frame
Visit 3
Title
Microbial Eradication
Description
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time Frame
Visit 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are at least one year of age. Subjects who have a clinical diagnosis of acute bacterial conjunctivitis. Subjects who are willing to discontinue contact lens wear for the duration of the study. Exclusion Criteria: Subjects who have any uncontrolled systemic disease or debilitating disease. Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs. Subjects who are expected to require treatment with any disallowed medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Paterno, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22644963
Citation
Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25.
Results Reference
derived
PubMed Identifier
22420526
Citation
DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000.
Results Reference
derived
PubMed Identifier
21397770
Citation
Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26. doi: 10.1016/j.clinthera.2010.12.004.
Results Reference
derived

Learn more about this trial

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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