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Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Primary Purpose

Dry Eye

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

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Visual Performance

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or more.
  • Non contact lens wearer.

  • Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

    • Score ≥13 for OSDI Questionnaire total score; AND
    • Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
  • Best visual acuity of 6/9 or better in each eye.
  • Willingness to adhere to the instructions set in the clinical protocol.
  • Signature of the subject informed consent form.

Exclusion Criteria:

  • Use of systemic medication which might produce dry eye side effects.
  • Systemic disease which might produce dry eye side effects.
  • Active ocular infection.
  • Use of ocular medication.
  • Significant ocular anomaly.
  • Previous ocular surgery
  • Previous use of Restasis
  • Any medical condition that might be prejudicial to the study.
  • The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
  • The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
  • The subject, based on their knowledge, must NOT have diabetes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Systane Ultra

    Optive

    Arm Description

    Systane Ultra Lubricant Eye Drops

    Optive Lubricant Eye Drops

    Outcomes

    Primary Outcome Measures

    Improvement in objective vision

    Secondary Outcome Measures

    Measurement of tear film evaporation

    Full Information

    First Posted
    January 18, 2010
    Last Updated
    January 31, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01051804
    Brief Title
    Evaluation of the Repeated Usage of Systane Ultra Eyedrop
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    July 2010 (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
    Comparison of two contact lens solutions.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Systane Ultra
    Arm Type
    Experimental
    Arm Description
    Systane Ultra Lubricant Eye Drops
    Arm Title
    Optive
    Arm Type
    Active Comparator
    Arm Description
    Optive Lubricant Eye Drops
    Intervention Type
    Other
    Intervention Name(s)
    Systane Ultra
    Intervention Description
    Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Optive lubricant Eye Drops
    Intervention Description
    Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks
    Primary Outcome Measure Information:
    Title
    Improvement in objective vision
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Measurement of tear film evaporation
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or more. Non contact lens wearer. Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire: Score ≥13 for OSDI Questionnaire total score; AND Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire Best visual acuity of 6/9 or better in each eye. Willingness to adhere to the instructions set in the clinical protocol. Signature of the subject informed consent form. Exclusion Criteria: Use of systemic medication which might produce dry eye side effects. Systemic disease which might produce dry eye side effects. Active ocular infection. Use of ocular medication. Significant ocular anomaly. Previous ocular surgery Previous use of Restasis Any medical condition that might be prejudicial to the study. The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment. The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus). The subject, based on their knowledge, must NOT have diabetes.

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Repeated Usage of Systane Ultra Eyedrop

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