Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

TearScience, Inc.139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Chalazion Dry Eye Syndromes

Interventions

Manual Mini SystemDEVICE

In-office device treatment for meibomian gland dysfunction by a physician

iHeat Portable Warm Compress TherapyDEVICE

At-home daily warm compress therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Fayetteville, Arkansas, United States

Unnamed facility

Morrow, Georgia, United States

Unnamed facility

Highland Park, Illinois, United States

Unnamed facility

Edgewood, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 2 Weeks and 4 Weeks

Incidence of Device-related Adverse Events

Number of eyes for which a device-related AE occurred

Time frame: 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.

Time frame: Baseline, 2 Weeks and 4 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline through 4 Weeks

Intraocular Pressure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.