Lipiflow Versus Warm Compresses in Parkinson's Disease

Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: LipiFlow system; Procedure: Warm compresses

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four visits up to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Four visits up to three months
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.	Four visits up to three months
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
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	Four visits up to three months
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.	Four visits up to three months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2016
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 3, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Eyelid Diseases; Parkinson Disease; Meibomian Gland Dysfunction
• Other Study ID Numbers: IRB00033387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes