Back to resultsEvaluation 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
About this trial
This is an interventional treatment trial for Chalazion
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
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
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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