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An Evaluation of the Safety and Efficacy of FID 114657

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 114657
Soothe XP 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 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
  • NaFl Corneal Staining sum score ≥ 3 in either eye

Exclusion Criteria:

  • Must not have worn contact lenses for 1 week preceding enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FID 114657

    Soothe XP Lubricant Eye Drops

    Arm Description

    FID 114657

    Soothe XP Lubricant Eye Drops

    Outcomes

    Primary Outcome Measures

    Tear Break-Up Time (TBUT)
    Corneal Staining
    Conjunctival Staining

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2009
    Last Updated
    February 1, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01030237
    Brief Title
    An Evaluation of the Safety and Efficacy of FID 114657
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (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 evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified 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
    Keywords
    Dry eye, artificial tears

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    153 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FID 114657
    Arm Type
    Experimental
    Arm Description
    FID 114657
    Arm Title
    Soothe XP Lubricant Eye Drops
    Arm Type
    Active Comparator
    Arm Description
    Soothe XP Lubricant Eye Drops
    Intervention Type
    Other
    Intervention Name(s)
    FID 114657
    Intervention Description
    1 drop both eyes four times a day for 6 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Soothe XP Lubricant Eye Drops
    Intervention Description
    1 drop both eyes four times a day for 6 weeks
    Primary Outcome Measure Information:
    Title
    Tear Break-Up Time (TBUT)
    Time Frame
    measured at Days 0, 7, 14, 28 and 42
    Title
    Corneal Staining
    Time Frame
    measured at Days 0, 7, 14, 28 and 42
    Title
    Conjunctival Staining
    Time Frame
    measured at Days 0, 7, 14, 28 and 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of dry eye NaFl Corneal Staining sum score ≥ 3 in either eye Exclusion Criteria: Must not have worn contact lenses for 1 week preceding enrollment

    12. IPD Sharing Statement

    Learn more about this trial

    An Evaluation of the Safety and Efficacy of FID 114657

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