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Acute Comfort of Lubricant Eye Drop FID 111421

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lubricant Eye Drop FID 111421
Optive 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
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lubricant Eye Drop FID 111421

    Optive Lubricant Eye Drop

    Arm Description

    Lubricant Eye Drop FID 111421 1 drop each eye one time

    Optive Lubricant Eye Drop 1 drop each eye one time

    Outcomes

    Primary Outcome Measures

    Drop Comfort Upon Instillation
    Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2008
    Last Updated
    January 31, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00673959
    Brief Title
    Acute Comfort of Lubricant Eye Drop FID 111421
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    February 2008 (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
    To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

    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
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lubricant Eye Drop FID 111421
    Arm Type
    Experimental
    Arm Description
    Lubricant Eye Drop FID 111421 1 drop each eye one time
    Arm Title
    Optive Lubricant Eye Drop
    Arm Type
    Active Comparator
    Arm Description
    Optive Lubricant Eye Drop 1 drop each eye one time
    Intervention Type
    Other
    Intervention Name(s)
    Lubricant Eye Drop FID 111421
    Intervention Description
    Lubricant Eye Drop FID 111421 1 drop each eye one time
    Intervention Type
    Other
    Intervention Name(s)
    Optive Lubricant Eye Drop
    Intervention Description
    Optive Lubricant Eye Drop 1 drop each eye one time
    Primary Outcome Measure Information:
    Title
    Drop Comfort Upon Instillation
    Description
    Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.
    Time Frame
    upon instillation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of dry eye Must not have worn contact lenses for 1 week preceding enrollment Exclusion Criteria: Age related

    12. IPD Sharing Statement

    Learn more about this trial

    Acute Comfort of Lubricant Eye Drop FID 111421

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