A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Primary Purpose
Acute Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Besifloxacin
Moxifloxacin solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Conjunctivitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Moxifloxacin solution
Besifloxacin Suspension
Arm Description
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Besifloxacin hydrochloride ophthalmic suspension 0.6%
Outcomes
Primary Outcome Measures
Clinical Resolution
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Microbial Eradication
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Secondary Outcome Measures
Clinical Resolution
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Microbial Eradication
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Full Information
NCT ID
NCT00348348
First Posted
June 30, 2006
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00348348
Brief Title
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Official Title
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (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 is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin solution
Arm Type
Active Comparator
Arm Description
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Arm Title
Besifloxacin Suspension
Arm Type
Experimental
Arm Description
Besifloxacin hydrochloride ophthalmic suspension 0.6%
Intervention Type
Drug
Intervention Name(s)
Besifloxacin
Intervention Description
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin solution
Intervention Description
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Primary Outcome Measure Information:
Title
Clinical Resolution
Description
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time Frame
Day 5(+/- 1 day)
Title
Microbial Eradication
Description
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame
Day 5 (+/- 1 day)
Secondary Outcome Measure Information:
Title
Clinical Resolution
Description
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Time Frame
Day 8 or Day 9
Title
Microbial Eradication
Description
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time Frame
Day 8 or Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Comstock, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
32841261
Citation
DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
Results Reference
derived
PubMed Identifier
20629472
Citation
Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
Results Reference
derived
Learn more about this trial
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
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