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Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.

Primary Purpose

Dry Eye Symptoms, Visual Performance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane® Ultra
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Symptoms focused on measuring Dry Eye, Visual Performance

Eligibility Criteria

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

Inclusion Criteria:

  • Player/ Coach must answer "Yes" to the survey eligibility question.
  • Player/Coach must voluntarily agree to participate in survey

Exclusion Criteria:

  • None.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Systane® Ultra

    Arm Description

    Systane® Ultra

    Outcomes

    Primary Outcome Measures

    Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2009
    Last Updated
    February 8, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00938951
    Brief Title
    Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    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
    The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Symptoms, Visual Performance
    Keywords
    Dry Eye, Visual Performance

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Systane® Ultra
    Arm Type
    Experimental
    Arm Description
    Systane® Ultra
    Intervention Type
    Other
    Intervention Name(s)
    Systane® Ultra
    Intervention Description
    Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%
    Primary Outcome Measure Information:
    Title
    Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session
    Time Frame
    60 minutes post-dosing with test article

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Player/ Coach must answer "Yes" to the survey eligibility question. Player/Coach must voluntarily agree to participate in survey Exclusion Criteria: None.

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.

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