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Lipiflow Versus Warm Compresses in Parkinson's Disease

Primary Purpose

Meibomian Gland Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LipiFlow system
Warm compresses
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

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

Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction

Inclusion Criteria:

  • Medical diagnosis of Parkinsons disease
  • > 18 years-old
  • Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit
  • Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid)
  • Willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study

Exclusion Criteria:

  • Active intraocular inflammation
  • Ocular surface abnormality that could potentially compromise corneal integrity in either eye

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lipiflow system

    Fellow eye warm compresses

    Arm Description

    Treatment through the use of heat and pulsatile pressure.

    Warm compresses to fellow eye and daily treatment with eyelid scrubs.

    Outcomes

    Primary Outcome Measures

    Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.
    Expressed secretion characteristics graded on a scale: 3 (clear liquid secretion) 2 (cloudy liquid secretion) 1 (inspissated/toothpaste consistency) 0 (no secretion) Meibomian gland metrics will be calculated: A) Total meibomian gland score (sum of the grades for all 15 glands with a range from 0 to 45) B) The number of glands secreting any liquid (clear or cloudy liquid with a grade of 2 or 3) of the 15 glands assessed C) The number of glands yielding the optimal clear liquid secretion (clear liquid with a grade of 3) of the 15 glands assessed.

    Secondary Outcome Measures

    Tear break up time
    Tear break up time defined measured with the fluorescein tear break up time (FBUT) method and categorized as follows "Dry" defined as FBUT values of 1-5 seconds "Marginal" defined as FBUT of 6-9 seconds "Normal" defined as FBUT of 10 or greater seconds
    Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment
    The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.
    Best spectacle-corrected visual acuity (BSCVA) with high-contrast Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart using the ETDRS-Fast method under standard illumination
    Corneal Staining
    • Corneal staining Evaluated with a slit-lamp biomicroscope 90 seconds after instillation of fluorescein dye using a standard strip method Corneal staining is based on the Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye and will be graded on a scale of 0 (none) - 3 (severe) with a total corneal staining grade range from 0 to 15
    SPEED Questionnaire assessment of dry eye symptoms before and after treatment
    SPEED Questionnaire rating of types, frequency, and severity of symptoms. Frequency is grade 0 to 3. Severity is grade 0 to 4. Higher grades represent greater disability.

    Full Information

    First Posted
    August 29, 2016
    Last Updated
    February 15, 2023
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02894658
    Brief Title
    Lipiflow Versus Warm Compresses in Parkinson's Disease
    Official Title
    Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of equipment
    Study Start Date
    August 2016 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction treatment.
    Detailed Description
    Objectives To determine whether a single treatment with thermal pulsation relieves dry eye symptoms (primary objective) and improves objective findings of meibomian gland dysfunction in patients with Parkinsons disease. Methods and Measures Design Randomized, controlled trial Patient eyes will be randomized to either receive a single thermal pulsation treatment the FDA-approved Lipiflow thermal pulsation system or to use traditional eyelid hygiene or to use traditional eyelid hygiene

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lipiflow system
    Arm Type
    Experimental
    Arm Description
    Treatment through the use of heat and pulsatile pressure.
    Arm Title
    Fellow eye warm compresses
    Arm Type
    Active Comparator
    Arm Description
    Warm compresses to fellow eye and daily treatment with eyelid scrubs.
    Intervention Type
    Device
    Intervention Name(s)
    LipiFlow system
    Intervention Description
    LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Warm compresses
    Intervention Description
    Warm compresses will be applied to fellow eye and that eye will undergo daily treatment with eyelid scrubs using a warm wash cloth and "no tears" baby shampoo every morning and warm compresses on the eyelids for 5-10 minutes twice a day. Patients will be instructed on how to perform proper lid hygiene at the initial visit.
    Primary Outcome Measure Information:
    Title
    Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.
    Description
    Expressed secretion characteristics graded on a scale: 3 (clear liquid secretion) 2 (cloudy liquid secretion) 1 (inspissated/toothpaste consistency) 0 (no secretion) Meibomian gland metrics will be calculated: A) Total meibomian gland score (sum of the grades for all 15 glands with a range from 0 to 45) B) The number of glands secreting any liquid (clear or cloudy liquid with a grade of 2 or 3) of the 15 glands assessed C) The number of glands yielding the optimal clear liquid secretion (clear liquid with a grade of 3) of the 15 glands assessed.
    Time Frame
    Four visits up to three months
    Secondary Outcome Measure Information:
    Title
    Tear break up time
    Description
    Tear break up time defined measured with the fluorescein tear break up time (FBUT) method and categorized as follows "Dry" defined as FBUT values of 1-5 seconds "Marginal" defined as FBUT of 6-9 seconds "Normal" defined as FBUT of 10 or greater seconds
    Time Frame
    Four visits up to three months
    Title
    Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment
    Description
    The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.
    Time Frame
    Four visits up to three months
    Title
    Best spectacle-corrected visual acuity (BSCVA) with high-contrast Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart using the ETDRS-Fast method under standard illumination
    Time Frame
    Four visits up to three months
    Title
    Corneal Staining
    Description
    • Corneal staining Evaluated with a slit-lamp biomicroscope 90 seconds after instillation of fluorescein dye using a standard strip method Corneal staining is based on the Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye and will be graded on a scale of 0 (none) - 3 (severe) with a total corneal staining grade range from 0 to 15
    Time Frame
    Four visits up to three months
    Title
    SPEED Questionnaire assessment of dry eye symptoms before and after treatment
    Description
    SPEED Questionnaire rating of types, frequency, and severity of symptoms. Frequency is grade 0 to 3. Severity is grade 0 to 4. Higher grades represent greater disability.
    Time Frame
    Four visits up to three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction Inclusion Criteria: Medical diagnosis of Parkinsons disease > 18 years-old Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid) Willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study Exclusion Criteria: Active intraocular inflammation Ocular surface abnormality that could potentially compromise corneal integrity in either eye
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan Burden, MD
    Organizational Affiliation
    Wake Forest Baptist Health Eye Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Lipiflow Versus Warm Compresses in Parkinson's Disease

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