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Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lubricant eye drop FID 115958D
Refresh PM Ointment
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

Exclusion Criteria:

  • Must not have worn contact lenses within 12 hours preceding enrollment
  • Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lubricant eye drop

    Refresh PM Ointment

    Arm Description

    Lubricant eye drop

    Refresh PM Ointment

    Outcomes

    Primary Outcome Measures

    Three-minute visual blur profile
    Overall Acceptability

    Secondary Outcome Measures

    Drop Comfort Upon Instillation

    Full Information

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

    Unique Protocol Identification Number
    NCT01076998
    Brief Title
    Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 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 compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.

    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
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lubricant eye drop
    Arm Type
    Experimental
    Arm Description
    Lubricant eye drop
    Arm Title
    Refresh PM Ointment
    Arm Type
    Active Comparator
    Arm Description
    Refresh PM Ointment
    Intervention Type
    Other
    Intervention Name(s)
    Lubricant eye drop FID 115958D
    Intervention Description
    1 drop in each eye, one time
    Intervention Type
    Other
    Intervention Name(s)
    Refresh PM Ointment
    Intervention Description
    1 drop in each eye, one time
    Primary Outcome Measure Information:
    Title
    Three-minute visual blur profile
    Time Frame
    Through 3 minutes (post-instillation)
    Title
    Overall Acceptability
    Time Frame
    Immediately upon instillation
    Secondary Outcome Measure Information:
    Title
    Drop Comfort Upon Instillation
    Time Frame
    Immediately upon installation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of dry eye Exclusion Criteria: Must not have worn contact lenses within 12 hours preceding enrollment Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

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