Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
NCT ID: NCT02102464
Last Updated: 2017-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2014-04-30
2015-09-30
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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LipiFlow
Single 12-minute LipiFlow treatment
LipiFlow treatment
The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized 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.
Untreated Control
Untreated Control (No Intervention)
No interventions assigned to this group
Crossover LipiFlow Treatment
Crossover LipiFlow treatment of the untreated control group after 3 months
LipiFlow treatment
The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized 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.
Interventions
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LipiFlow treatment
The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Willing to comply with randomization, attend all study visits and follow patient instructions
* Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
* No change in contact lens type or dimensions for the past 3 months
* Clinician assessment of acceptable contact lens fit and disinfecting solution
* Tear film interferometry of 100 units or less
Exclusion Criteria
* Use of systemic medications known to cause dryness
* History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
* Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
* Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
* Participation in another ophthalmic drug or device trial in the past month
* Employee, relative of employee or associate of the clinical site
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 Coleman, OD, MPH
Role: STUDY_DIRECTOR
TearScience, Inc.
Locations
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School of Optometry, The University of Alabama at Birmingham
Birmingham, Alabama, United States
Clayton Eye Center
Morrow, Georgia, United States
Charlotte Eye Ear Nose and Throat Associates, P.A.
Charlotte, North Carolina, United States
May Eye Care Center & Associates
Hanover, Pennsylvania, United States
Specialty Eyecare Group
Kirkland, Washington, United States
Centre for Contact Lens Research
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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LF006
Identifier Type: -
Identifier Source: org_study_id