Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

TearScience

Status: Completed

Conditions: Dry Eye Syndromes; Chalazion

Treatments: Device: iHeat Portable Warm Compress Therapy; Device: Manual Mini System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832130

LF001

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Manual Mini System

Experimental group

Description:

Treatment with experimental Manual Mini System

Treatment:

Device: Manual Mini System

Warm Compress Therapy

Active Comparator group

Description:

Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase

Treatment:

Device: Manual Mini System

Device: iHeat Portable Warm Compress Therapy