Back to resultsTreatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Primary Purpose
Chalazion, Dry Eye Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Mini System
iHeat Portable Warm Compress Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chalazion
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age.
- Meibomian gland obstruction
- Dry eye symptoms
- Willingness to comply with study procedures and return for all visits
Exclusion Criteria:
- Ocular surgery, injury, or 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
- Macular disease
- Systemic disease condition or medication that causes 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 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual Mini System
Warm Compress Therapy
Arm Description
Treatment with experimental Manual Mini System
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Outcomes
Primary Outcome Measures
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.
Incidence of Device-related Adverse Events
Number of eyes for which a device-related AE occurred
Tear Break-up Time
Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.
Secondary Outcome Measures
Dry Eye Symptoms (Total SPEED Score)
Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.
Ocular Surface Staining (Corneal Staining Sum Score)
Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.
Intraocular Pressure
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
(LogMAR) Best Spectacle Corrected Visual Acuity
Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.
Discomfort Evaluation (Discomfort/Pain Score)
Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00832130
Brief Title
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Official Title
Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (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 of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat 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.
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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Mini System
Arm Type
Experimental
Arm Description
Treatment with experimental Manual Mini System
Arm Title
Warm Compress Therapy
Arm Type
Active Comparator
Arm Description
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Intervention Type
Device
Intervention Name(s)
Manual Mini System
Intervention Description
In-office device treatment for meibomian gland dysfunction by a physician
Intervention Type
Device
Intervention Name(s)
iHeat Portable Warm Compress Therapy
Intervention Description
At-home daily warm compress therapy
Primary Outcome Measure Information:
Title
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Description
Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.
Time Frame
Baseline, 2 Weeks and 4 Weeks
Title
Incidence of Device-related Adverse Events
Description
Number of eyes for which a device-related AE occurred
Time Frame
Baseline through 4 Weeks
Title
Tear Break-up Time
Description
Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.
Time Frame
Baseline, 2 Weeks and 4 Weeks
Secondary Outcome Measure Information:
Title
Dry Eye Symptoms (Total SPEED Score)
Description
Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.
Time Frame
Baseline, 2 Weeks and 4 Weeks
Title
Ocular Surface Staining (Corneal Staining Sum Score)
Description
Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.
Time Frame
Baseline through 4 Weeks
Title
Intraocular Pressure
Description
Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.
Time Frame
Baseline through 4 Weeks
Title
(LogMAR) Best Spectacle Corrected Visual Acuity
Description
Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.
Time Frame
Baseline, 2 Weeks and 4 Weeks
Title
Discomfort Evaluation (Discomfort/Pain Score)
Description
Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.
Time Frame
Treatment and 1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age.
Meibomian gland obstruction
Dry eye symptoms
Willingness to comply with study procedures and return for all visits
Exclusion Criteria:
Ocular surgery, injury, or 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
Macular disease
Systemic disease condition or medication that causes 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, Inc.
Official's Role
Study Director
Facility Information:
City
Fayetteville
State/Province
Arkansas
Country
United States
City
Morrow
State/Province
Georgia
Country
United States
City
Highland Park
State/Province
Illinois
Country
United States
City
Edgewood
State/Province
Kentucky
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Winchester
State/Province
Massachusetts
Country
United States
City
Jackson
State/Province
Michigan
Country
United States
City
Bloomington
State/Province
Minnesota
Country
United States
City
Stillwater
State/Province
Minnesota
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
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