Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
NCT ID: NCT00832130
Last Updated: 2011-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2009-02-28
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Manual Mini System
Treatment with experimental Manual Mini System
Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
Warm Compress Therapy
Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
iHeat Portable Warm Compress Therapy
At-home daily warm compress therapy
Interventions
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Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
iHeat Portable Warm Compress Therapy
At-home daily warm compress therapy
Eligibility Criteria
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Inclusion Criteria
* Meibomian gland obstruction
* Dry eye symptoms
* Willingness to comply with study procedures and return for all visits
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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TearScience, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christy Stevens, OD
Role: STUDY_DIRECTOR
TearScience, Inc.
Locations
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Fayetteville, Arkansas, United States
Morrow, Georgia, United States
Highland Park, Illinois, United States
Edgewood, Kentucky, United States
Lexington, Kentucky, United States
Winchester, Massachusetts, United States
Jackson, Michigan, United States
Bloomington, Minnesota, United States
Stillwater, Minnesota, United States
Charlotte, North Carolina, United States
Lancaster, Pennsylvania, United States
Countries
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Other Identifiers
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LF001
Identifier Type: -
Identifier Source: org_study_id