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Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Systane Ultra 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, Tear Film Stability

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18 years or more.
  2. Subjects must have Tear Break Up Time (TBUT) < 5 seconds
  3. Subjects must have a maximum blink interval (MBI) < 10 seconds
  4. Subjects must be willing to comply with all study requirements.
  5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
  2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
  3. Subjects with known sensitivity to planned study concomitant medications
  4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
  5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Systane Ultra

    Arm Description

    Systane Ultra Lubricant Eye Drops

    Outcomes

    Primary Outcome Measures

    Improvement in maximum blink interval (MBI)

    Secondary Outcome Measures

    Tear film stability and contrast sensitivity

    Full Information

    First Posted
    March 12, 2010
    Last Updated
    January 31, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01086774
    Brief Title
    Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    November 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
    Evaluation of the optical effects of Systane Ultra

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye
    Keywords
    Dry eye, Tear Film Stability

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Systane Ultra
    Arm Type
    Experimental
    Arm Description
    Systane Ultra Lubricant Eye Drops
    Intervention Type
    Other
    Intervention Name(s)
    Systane Ultra Lubricant Eye Drops
    Intervention Description
    Single drop in both eyes
    Primary Outcome Measure Information:
    Title
    Improvement in maximum blink interval (MBI)
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Tear film stability and contrast sensitivity
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or more. Subjects must have Tear Break Up Time (TBUT) < 5 seconds Subjects must have a maximum blink interval (MBI) < 10 seconds Subjects must be willing to comply with all study requirements. Subjects must understand, sign and be given a copy of the written Informed Consent form. Exclusion Criteria: Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria Subjects who are pregnant, lactating or planning to be pregnant during the course of the study Subjects with known sensitivity to planned study concomitant medications Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

    12. IPD Sharing Statement

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    Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

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