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Artificial Tears Study in Mild to Moderate Dry Eye Patients

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Systane
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry, eyes, Amelioration of dry eye symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mild to moderate dry eye
  • over 18

Exclusion Criteria:

  • No concurrent ocular disease or meds

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Systane

    Blink tears

    Outcomes

    Primary Outcome Measures

    Subjective ocular comfort

    Secondary Outcome Measures

    Vision quality

    Full Information

    First Posted
    December 19, 2007
    Last Updated
    February 5, 2008
    Sponsor
    Abbott Medical Optics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00607776
    Brief Title
    Artificial Tears Study in Mild to Moderate Dry Eye Patients
    Official Title
    Artificial Tears Study in Mild to Moderate Dry Eye Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott Medical Optics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye
    Keywords
    dry, eyes, Amelioration of dry eye symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Systane
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Blink tears
    Intervention Type
    Drug
    Intervention Name(s)
    (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
    Intervention Description
    Drops
    Intervention Type
    Drug
    Intervention Name(s)
    Systane
    Intervention Description
    Drops
    Primary Outcome Measure Information:
    Title
    Subjective ocular comfort
    Time Frame
    1 Month
    Secondary Outcome Measure Information:
    Title
    Vision quality
    Time Frame
    1 Month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Mild to moderate dry eye over 18 Exclusion Criteria: No concurrent ocular disease or meds
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Donnenfeld, M.D.
    Organizational Affiliation
    Ophthalmic Consultants of Long Island
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Artificial Tears Study in Mild to Moderate Dry Eye Patients

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