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Systane Clinical Experience Study

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Systane
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry eye, Systane, Moderate to severe dry eye

Eligibility Criteria

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

Inclusion Criteria:

  • moderate to severe dry feeling eyes

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Systane

    Arm Description

    Systane ocular product

    Outcomes

    Primary Outcome Measures

    corneal and conjunctiva staining score

    Secondary Outcome Measures

    Tear film break up time

    Full Information

    First Posted
    January 7, 2009
    Last Updated
    January 31, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00818909
    Brief Title
    Systane Clinical Experience Study
    Official Title
    Study to Evaluate the Physical Effect of SYSTANE QID in People That Have Moderate to Severe Dry Feeling Eyes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    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 evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome
    Keywords
    Dry eye, Systane, Moderate to severe dry eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    941 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Systane
    Arm Type
    Experimental
    Arm Description
    Systane ocular product
    Intervention Type
    Other
    Intervention Name(s)
    Systane
    Intervention Description
    Systane prescription
    Primary Outcome Measure Information:
    Title
    corneal and conjunctiva staining score
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Tear film break up time
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: moderate to severe dry feeling eyes Exclusion Criteria: None

    12. IPD Sharing Statement

    Learn more about this trial

    Systane Clinical Experience Study

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