Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

Official Title
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Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Conditions
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Chalazion, Dry Eye Syndromes

Intervention / Treatment
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* Device: Manual Mini System
* Device: iHeat Portable Warm Compress Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. Meibomian gland obstruction Dry eye symptoms Willingness to comply with study procedures and return for all visits Exclusion Criteria: Ocular surgery, injury, or herpes infection within past 3 months Active ocular infection Active ocular inflammation or recurrent inflammation within past 3 months Moderate to severe allergic conjunctivitis Severe eyelid inflammation Eyelid abnormalities that affect lid function Ocular surface abnormalities that may compromise corneal integrity Macular disease Systemic disease condition or medication that causes dry eye Use of other treatments for meibomian gland dysfunction or dry eye Pregnant or nursing women Participation in another ophthalmic clinical trial within past 30 days

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: Manual Mini System<br>Treatment with experimental Manual Mini System | Device: Manual Mini System<br>* In-office device treatment for meibomian gland dysfunction by a physician<br>|
| Active Comparator: Warm Compress Therapy<br>Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase | Device: Manual Mini System<br>* In-office device treatment for meibomian gland dysfunction by a physician<br>Device: iHeat Portable Warm Compress Therapy<br>* At-home daily warm compress therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) | Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45. | Baseline, 2 Weeks and 4 Weeks | 
| Incidence of Device-related Adverse Events | Number of eyes for which a device-related AE occurred | Baseline through 4 Weeks | 
| Tear Break-up Time | Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability. | Baseline, 2 Weeks and 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye Symptoms (Total SPEED Score) | Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms. | Baseline, 2 Weeks and 4 Weeks | 
| Ocular Surface Staining (Corneal Staining Sum Score) | Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation. | Baseline through 4 Weeks | 
| Intraocular Pressure | Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety. | Baseline through 4 Weeks | 
| (LogMAR) Best Spectacle Corrected Visual Acuity | Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity. | Baseline, 2 Weeks and 4 Weeks | 
| Discomfort Evaluation (Discomfort/Pain Score) | Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain. | Treatment and 1 Day |