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Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

Primary Purpose

Bacterial Conjunctivitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
AL-15469A 0.5%
AL-6515 0.3%
Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients of any race
  • 5 years of age and older at the time of the Day 1 visit
  • with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion Criteria:

  • Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
  • Presence of punctal plug or punctal occlusion
  • Visual Acuity worse than 20/80
  • Upper respiratory infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension

    AL-15469A 0.5%

    AL-6515 0.3%

    Vehicle

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sustained Clinical Cure rate
    End of therapy Clinical Cure rate

    Secondary Outcome Measures

    Sustained bulbar conjunctival injection
    Microbiological Success

    Full Information

    First Posted
    November 9, 2010
    Last Updated
    November 29, 2011
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01238783
    Brief Title
    Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2011 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis

    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
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
    Arm Type
    Experimental
    Arm Title
    AL-15469A 0.5%
    Arm Type
    Experimental
    Arm Title
    AL-6515 0.3%
    Arm Type
    Experimental
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
    Intervention Description
    Topical ocular dosed 3 times per day for 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-15469A 0.5%
    Intervention Description
    Topical ocular dosed 3 times per day for 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-6515 0.3%
    Intervention Description
    Topical ocular dosed 3 times per day for 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle
    Intervention Description
    Topical ocular dosed 3 times per day for 3 days
    Primary Outcome Measure Information:
    Title
    Sustained Clinical Cure rate
    Time Frame
    Day 3
    Title
    End of therapy Clinical Cure rate
    Time Frame
    Day 4
    Secondary Outcome Measure Information:
    Title
    Sustained bulbar conjunctival injection
    Time Frame
    Day 3
    Title
    Microbiological Success
    Time Frame
    Day 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female patients of any race 5 years of age and older at the time of the Day 1 visit with a primary clinical diagnosis of bacterial conjunctivitis. Exclusion Criteria: Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days Presence of punctal plug or punctal occlusion Visual Acuity worse than 20/80 Upper respiratory infection

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

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