Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
1 other identifier
interventional
139
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2009
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
December 6, 2011
CompletedDecember 12, 2011
December 1, 2011
4 months
January 27, 2009
September 19, 2011
December 5, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline, 2 Weeks and 4 Weeks
Incidence of Device-related Adverse Events
Number of eyes for which a device-related AE occurred
Baseline through 4 Weeks
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.
Baseline, 2 Weeks and 4 Weeks
Secondary Outcomes (5)
Dry Eye Symptoms (Total SPEED Score)
Baseline, 2 Weeks and 4 Weeks
Ocular Surface Staining (Corneal Staining Sum Score)
Baseline through 4 Weeks
Intraocular Pressure
Baseline through 4 Weeks
(LogMAR) Best Spectacle Corrected Visual Acuity
Baseline, 2 Weeks and 4 Weeks
Discomfort Evaluation (Discomfort/Pain Score)
Treatment and 1 Day
Study Arms (2)
Manual Mini System
EXPERIMENTALTreatment with experimental Manual Mini System
Warm Compress Therapy
ACTIVE COMPARATORControl group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Interventions
In-office device treatment for meibomian gland dysfunction by a physician
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- Meibomian gland obstruction
- Dry eye symptoms
- Willingness to comply with study procedures and return for all visits
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Fayetteville, Arkansas, United States
Unknown Facility
Morrow, Georgia, United States
Unknown Facility
Highland Park, Illinois, United States
Unknown Facility
Edgewood, Kentucky, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Winchester, Massachusetts, United States
Unknown Facility
Jackson, Michigan, United States
Unknown Facility
Bloomington, Minnesota, United States
Unknown Facility
Stillwater, Minnesota, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Lancaster, Pennsylvania, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christy Stevens, OD
- Organization
- TearScience, Inc. (formerly Kolis Scientific)
Study Officials
- STUDY DIRECTOR
Christy Stevens, OD
TearScience, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 29, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
December 12, 2011
Results First Posted
December 6, 2011
Record last verified: 2011-12