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An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 115958D (Lubricant Eye Drop)
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, artificial tears

Eligibility Criteria

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

Inclusion Criteria:

  • Documented diagnosis of dry eye
  • Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily

Exclusion Criteria:

  • Must not have worn contact lenses within 7 days preceding enrollment
  • Must not have had punctal plugs inserted within 30 days preceding enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FID 115958D

    Arm Description

    Lubricant eye drop

    Outcomes

    Primary Outcome Measures

    Daytime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2010
    Last Updated
    February 1, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01139372
    Brief Title
    An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
    Official Title
    An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (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
    The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FID 115958D
    Arm Type
    Experimental
    Arm Description
    Lubricant eye drop
    Intervention Type
    Other
    Intervention Name(s)
    FID 115958D (Lubricant Eye Drop)
    Intervention Description
    1 drop in each eye at least twice daily
    Primary Outcome Measure Information:
    Title
    Daytime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)
    Time Frame
    Day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of dry eye Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily Exclusion Criteria: Must not have worn contact lenses within 7 days preceding enrollment Must not have had punctal plugs inserted within 30 days preceding enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop

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