Lipiflow Versus Warm Compresses in Parkinson's Disease

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Suspended
CT.gov ID
NCT02894658
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
80
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: LipiFlow system
  • Procedure: Warm compresses
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Lipiflow system

Treatment through the use of heat and pulsatile pressure.

Device: LipiFlow system
LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.

Active Comparator: Fellow eye warm compresses

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

Procedure: Warm compresses
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.

Outcome Measures

Primary Outcome Measures

  1. Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator. [Four visits up to three months]

    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

  1. Tear break up time [Four visits up to three months]

    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

  2. Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment [Four visits up to three months]

    The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.

  3. 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 [Four visits up to three months]

  4. Corneal Staining [Four visits up to three months]

    • 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

  5. SPEED Questionnaire assessment of dry eye symptoms before and after treatment [Four visits up to three months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wake Forest Baptist Health Eye CenterWinston-SalemNorth CarolinaUnited States27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Susan Burden, MD, Wake Forest Baptist Health Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02894658
Other Study ID Numbers:
  • IRB00033387
First Posted:
Sep 9, 2016
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2020