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Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

Primary Purpose

Blepharoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
1% Azithromycin and 0.1% Dexamethasone
1% Azithromycin
0.1% Dexamethasone
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoconjunctivitis focused on measuring Blepharoconjunctivitis, Ophthalmology

Eligibility Criteria

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

Inclusion Criteria:

  • Have a clinical diagnosis of blepharoconjunctivitis
  • Must be willing to discontinue contact lens wear for the duration of the study
  • Additional inclusion criteria also apply.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to any component of the study medications.
  • Have any clinically significant cardiovascular disorders
  • Have any history of liver or kidney disease resulting in persisting dysfunction
  • Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
  • Additional exclusion criteria also apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Outcomes

    Primary Outcome Measures

    The resolution of the clinical signs and symptoms.

    Secondary Outcome Measures

    Bacterial eradication

    Full Information

    First Posted
    December 19, 2007
    Last Updated
    November 18, 2021
    Sponsor
    Sun Pharmaceutical Industries Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00578955
    Brief Title
    Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
    Official Title
    A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Pharmaceutical Industries Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blepharoconjunctivitis
    Keywords
    Blepharoconjunctivitis, Ophthalmology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    417 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Title
    3
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    1% Azithromycin and 0.1% Dexamethasone
    Other Intervention Name(s)
    AzaSite Plus
    Intervention Description
    Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
    Intervention Type
    Drug
    Intervention Name(s)
    1% Azithromycin
    Other Intervention Name(s)
    AzaSite
    Intervention Description
    Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
    Intervention Type
    Drug
    Intervention Name(s)
    0.1% Dexamethasone
    Other Intervention Name(s)
    Dexamethasone
    Intervention Description
    Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
    Primary Outcome Measure Information:
    Title
    The resolution of the clinical signs and symptoms.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Bacterial eradication
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have a clinical diagnosis of blepharoconjunctivitis Must be willing to discontinue contact lens wear for the duration of the study Additional inclusion criteria also apply. Exclusion Criteria: Have known sensitivity or poor tolerance to any component of the study medications. Have any clinically significant cardiovascular disorders Have any history of liver or kidney disease resulting in persisting dysfunction Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device. Additional exclusion criteria also apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

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