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A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

Primary Purpose

Blepharitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Azithromycin ophthalmic solution, 1%
Vehicle
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a current diagnosis of blepharitis
  • Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

  • If female, are non-pregnant or non-lactating

Exclusion Criteria:

  • Have a concurrent acute hordeolum (stye) or chalazion
  • Have inflammation of the ocular surface
  • Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

  • Have had ocular surgery in the past 90 days or will require it during the

study

  • Unable to withhold the use of contact lenses during the study
  • Have a known hypersensitivity to azithromycin, erythromycin, any other

macrolide antibiotic, or any of the other ingredients in the study

medication

  • Have been diagnosed with ongoing glaucoma
  • Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

  • Have a serious medical condition which could confound study assessments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Azithromycin ophthalmic solution, 1%

    Vehicle

    Arm Description

    Outcomes

    Primary Outcome Measures

    Resolution of clinical signs of blepharitis

    Secondary Outcome Measures

    Time to first clinical resolution
    Mean and change from baseline for clinical signs of blepharitis
    Mean and change from end of dosing for clinical signs of blepharitis
    Response to the Blepharitis Symptoms Questionnaire (BSQ)

    Full Information

    First Posted
    December 21, 2010
    Last Updated
    October 29, 2013
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01269658
    Brief Title
    A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
    Official Title
    A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blepharitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Azithromycin ophthalmic solution, 1%
    Arm Type
    Experimental
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin ophthalmic solution, 1%
    Intervention Description
    1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle
    Intervention Description
    1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
    Primary Outcome Measure Information:
    Title
    Resolution of clinical signs of blepharitis
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    Time to first clinical resolution
    Time Frame
    Days 7, 14, 21, 28, 42, 56, 70, and 84
    Title
    Mean and change from baseline for clinical signs of blepharitis
    Time Frame
    Days 7, 14, 21, 28, 42, 56, 70, and 84
    Title
    Mean and change from end of dosing for clinical signs of blepharitis
    Time Frame
    Days 42, 56, 70, and 84
    Title
    Response to the Blepharitis Symptoms Questionnaire (BSQ)
    Time Frame
    Days 1, 7, 14, 21, 28, 42, 56, 70, and 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a current diagnosis of blepharitis Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 If female, are non-pregnant or non-lactating Exclusion Criteria: Have a concurrent acute hordeolum (stye) or chalazion Have inflammation of the ocular surface Have used artificial tears within 48 hours prior to Visit 1 or anticipate using during the study Have had ocular surgery in the past 90 days or will require it during the study Unable to withhold the use of contact lenses during the study Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication Have been diagnosed with ongoing glaucoma Unable to withhold the use of ocular cosmetic products within 48 hours prior to Visit 1 and throughout the study Have a serious medical condition which could confound study assessments
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Johnson, MBChB
    Organizational Affiliation
    Chief Medical Officer
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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