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A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Primary Purpose

Moderate to Severe Dry Eye

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 Moderate to Severe Dry Eye focused on measuring Systane, Dry Eye

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older, of both sexes, and any race.
  • Willing and able to make all required visits and follow study instructions.
  • A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart

Exclusion Criteria:

  • A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
  • Lasik patients can be included if Lasik surgery was > 6 months prior to the initiation of the study.
  • A history of intolerance or hypersensitivity to any component of the study medications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Systane

    Arm Description

    Systane Lubricant Eye Drops

    Outcomes

    Primary Outcome Measures

    Corneal Staining
    Best-corrected visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2011
    Last Updated
    January 31, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01311609
    Brief Title
    A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
    Official Title
    Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (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
    This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.
    Detailed Description
    This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Dry Eye
    Keywords
    Systane, 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
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Systane
    Arm Type
    Experimental
    Arm Description
    Systane Lubricant Eye Drops
    Intervention Type
    Other
    Intervention Name(s)
    Systane
    Intervention Description
    Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]
    Primary Outcome Measure Information:
    Title
    Corneal Staining
    Time Frame
    Visit 2 (Week 2) - change from baseline
    Title
    Best-corrected visual acuity
    Time Frame
    Visit 2 (Week 2) - change from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older, of both sexes, and any race. Willing and able to make all required visits and follow study instructions. A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart Exclusion Criteria: A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. Lasik patients can be included if Lasik surgery was > 6 months prior to the initiation of the study. A history of intolerance or hypersensitivity to any component of the study medications.

    12. IPD Sharing Statement

    Learn more about this trial

    A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

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