Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

TearScience

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dry Eye Syndromes; Chalazion

Treatments: Device: LipiFlow System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202747

LF002

Details and patient eligibility

About

The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure 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. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meibomian gland dysfunction
• Dry Eye symptoms

Exclusion criteria

• Ocular surgery, ocular injury or ocular 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
• Systemic disease conditions or medications that cause 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

LipiFlow Treatment

Experimental group

Description:

Treatment with LipiFlow device

Treatment:

Device: LipiFlow System