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The Effect of Tear Supplements on Contact Lens Comfort

Primary Purpose

Dry Eye Syndromes, Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systane Balance eye drops
Systane Contacts eye drops
saline
Sponsored by
University of the Incarnate Word
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

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

Inclusion Criteria:

  • Patients complaining of contact lens associated discomfort

Exclusion Criteria:

  • Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Lipid based artificial tears

    Non-lipid based artificial tears

    Saline

    Arm Description

    Patients use lipid based artificial tears

    patients use non-lipid based artificial tears

    patients use saline

    Outcomes

    Primary Outcome Measures

    Contact Lens Discomfort Questionnaire
    CLDEQ Questionnaire will be used to quantify contact lens discomfort

    Secondary Outcome Measures

    Fluorescein tear break-up time
    Fluorescein will be instilled in the conjunctival sac to assess tear break-up time

    Full Information

    First Posted
    November 1, 2016
    Last Updated
    November 2, 2016
    Sponsor
    University of the Incarnate Word
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02956083
    Brief Title
    The Effect of Tear Supplements on Contact Lens Comfort
    Official Title
    The Effect of Tear Supplements on Contact Lens Comfort
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of the Incarnate Word

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).
    Detailed Description
    Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndromes, Meibomian Gland Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lipid based artificial tears
    Arm Type
    Active Comparator
    Arm Description
    Patients use lipid based artificial tears
    Arm Title
    Non-lipid based artificial tears
    Arm Type
    Active Comparator
    Arm Description
    patients use non-lipid based artificial tears
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    patients use saline
    Intervention Type
    Other
    Intervention Name(s)
    Systane Balance eye drops
    Intervention Description
    Propylene Glycol 0.6% Over the counter lipid based artificial tears.
    Intervention Type
    Other
    Intervention Name(s)
    Systane Contacts eye drops
    Intervention Description
    Hydroxypropyl methycellulose over the counter non-lipid based artificial tears
    Intervention Type
    Other
    Intervention Name(s)
    saline
    Intervention Description
    Saline - no brand name
    Primary Outcome Measure Information:
    Title
    Contact Lens Discomfort Questionnaire
    Description
    CLDEQ Questionnaire will be used to quantify contact lens discomfort
    Time Frame
    1 months
    Secondary Outcome Measure Information:
    Title
    Fluorescein tear break-up time
    Description
    Fluorescein will be instilled in the conjunctival sac to assess tear break-up time
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients complaining of contact lens associated discomfort Exclusion Criteria: Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Srihari Narayanan, OD, PhD
    Organizational Affiliation
    University of the Incarnate Word
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Tear Supplements on Contact Lens Comfort

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