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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
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Conjunctivitis

Eligibility Criteria

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

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

    First Posted
    June 30, 2006
    Last Updated
    March 4, 2015
    Sponsor
    Bausch & Lomb Incorporated
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    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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