Lipiflow Versus Warm Compresses in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: LipiFlow system
* Procedure: Warm compresses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipiflow system<br>Treatment through the use of heat and pulsatile pressure. | Device: LipiFlow system<br>* LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.<br>|
| Active Comparator: Fellow eye warm compresses<br>Warm compresses to fellow eye and daily treatment with eyelid scrubs. | Procedure: Warm compresses<br>* 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.<br>|

What is the study measuring?
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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 |