Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

• Sponsor: TearScience, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01202747
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Duration (Months): 4
• Patients Per Site: 16.7
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chalazion; Dry Eye Syndromes	Device: LipiFlow System	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study for Evaluation of LipiFlow Screening Methods
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LipiFlow Treatment Treatment with LipiFlow device	Device: LipiFlow System; In-office treatment for meibomian gland dysfunction

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hoffman Estates	Illinois	United States
2		Boston	Massachusetts	United States
3		Winchester	Massachusetts	United States

Sponsors and Collaborators

• TearScience, Inc.

Investigators

• Study Director: Christy Stevens, OD, TearScience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TearScience, Inc.
• ClinicalTrials.gov Identifier: NCT01202747
• Other Study ID Numbers: LF002
• First Posted: Sep 16, 2010
• Last Update Posted: Dec 6, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Chalazion; Dry Eye Syndromes

Study Results

Participant Flow

Recruitment Details	A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.

Arm/Group Title	LipiFlow Treatment
Arm/Group Description	Treatment with LipiFlow device
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	LipiFlow Treatment
Arm/Group Description	Treatment with LipiFlow device
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (15.9)
Sex: Female, Male (Count of Participants)
Female	35 70%
Male	15 30%

Outcome Measures

1. Primary Outcome

Title	Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
Description	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.
Time Frame	Baseline and 4 Weeks

Outcome Measure Data

Analysis Population Description

Results presented are for the Intent to Treat population.

Arm/Group Title	LipiFlow Treatment
Arm/Group Description	Treatment with LipiFlow device
Measure Participants	50
Number [Correlation coefficient]	0.4816

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LipiFlow Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	p<0.05 considered statistically significant
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	4 Weeks
Arm/Group Title	LipiFlow Treatment
Arm/Group Description	Treatment with LipiFlow device
All Cause Mortality
	LipiFlow Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	LipiFlow Treatment
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	LipiFlow Treatment
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.