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Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Primary Purpose

Chalazion, Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LipiFlow System
Sponsored by
TearScience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chalazion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LipiFlow Treatment

Arm Description

Treatment with LipiFlow device

Outcomes

Primary Outcome Measures

Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2010
Last Updated
November 1, 2011
Sponsor
TearScience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01202747
Brief Title
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Official Title
Pilot Study for Evaluation of LipiFlow Screening Methods
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TearScience, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LipiFlow Treatment
Arm Type
Experimental
Arm Description
Treatment with LipiFlow device
Intervention Type
Device
Intervention Name(s)
LipiFlow System
Intervention Description
In-office treatment for meibomian gland dysfunction
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy Stevens, OD
Organizational Affiliation
TearScience
Official's Role
Study Director
Facility Information:
City
Hoffman Estates
State/Province
Illinois
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Winchester
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

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