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Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Emulsion type artificial tear
Sponsored by
Hom, Milton M., OD, FAAO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Artificial tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between the ages of 18 and over inclusive.
  • Males or females
  • Patient is in generally good & stable overall health.
  • Patient likely to comply with study guidelines & study visits.
  • Informed consent signed.
  • OSDI score >18 OR
  • TBUT <10 seconds

Exclusion Criteria:

  • Corneal refractive surgery or contact lens wear within 6 months of this study.
  • Current use of Restasis
  • Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  • Pregnant or lactating women.
  • Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Test

    Arm Description

    Outcomes

    Primary Outcome Measures

    Tolerability Questionnaire
    Tolerability (comfort) measured with Visual Analog scale (1 to 100)

    Secondary Outcome Measures

    Acceptability Questionnaire
    Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)
    Tear Break Up Time
    Tear Break Up Time measured in seconds

    Full Information

    First Posted
    April 12, 2011
    Last Updated
    April 13, 2011
    Sponsor
    Hom, Milton M., OD, FAAO
    Collaborators
    Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01335126
    Brief Title
    Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
    Official Title
    Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    October 2011 (Anticipated)
    Study Completion Date
    November 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hom, Milton M., OD, FAAO
    Collaborators
    Allergan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Emulsion type artificial tear
    Intervention Description
    2 types of artificial tears
    Primary Outcome Measure Information:
    Title
    Tolerability Questionnaire
    Description
    Tolerability (comfort) measured with Visual Analog scale (1 to 100)
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Acceptability Questionnaire
    Description
    Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)
    Time Frame
    8 weeks
    Title
    Tear Break Up Time
    Description
    Tear Break Up Time measured in seconds
    Time Frame
    2-3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Between the ages of 18 and over inclusive. Males or females Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. OSDI score >18 OR TBUT <10 seconds Exclusion Criteria: Corneal refractive surgery or contact lens wear within 6 months of this study. Current use of Restasis Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milton M Hom, OD FAAO
    Organizational Affiliation
    Private Practice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

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