search
Back to results

An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® Balance 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 Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SYSTANE® Balance Lubricant Eye Drops

    Arm Description

    SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.

    Outcomes

    Primary Outcome Measures

    Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.

    Secondary Outcome Measures

    Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
    Fluorescein staining at Visits 1 & 3 on the Ora staining scale
    Ocular Symptomology at each visit

    Full Information

    First Posted
    October 15, 2010
    Last Updated
    April 7, 2012
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01223040
    Brief Title
    An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    September 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
    The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    SYSTANE® Balance Lubricant Eye Drops
    Arm Type
    Experimental
    Arm Description
    SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
    Intervention Type
    Other
    Intervention Name(s)
    SYSTANE® Balance Lubricant Eye Drops
    Intervention Description
    Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
    Primary Outcome Measure Information:
    Title
    Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
    Time Frame
    8 days
    Secondary Outcome Measure Information:
    Title
    Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
    Time Frame
    9 days
    Title
    Fluorescein staining at Visits 1 & 3 on the Ora staining scale
    Time Frame
    9 days
    Title
    Ocular Symptomology at each visit
    Time Frame
    9 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months Exclusion Criteria: Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

    12. IPD Sharing Statement

    Learn more about this trial

    An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

    We'll reach out to this number within 24 hrs