Lipiflow Versus Warm Compresses in Parkinson's Disease

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02894658
• Other study ID #: IRB00033387
• Status: Withdrawn
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 2023

Study information

• Verified date: December 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• Parkinson Disease

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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