Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Phase 2

Completed

• Conditions: Chalazion; Dry Eye Syndromes
• Interventions: Device: LipiFlow System

• Registration Number: NCT01202747
• Lead Sponsor: TearScience, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-09-16
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-01
• Last Update Submitted: 2011-11-01
• Results First Posted: 2011-12-06
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LipiFlow Treatment	LipiFlow System	Treatment with LipiFlow device

Primary Outcome Measures

Name	Time	Method
Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)	Baseline and 4 Weeks	Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p\<0.05) association between the screening method and outcome.; Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.