Status:
COMPLETED
Lipiflow vs iLux Patient Acceptance and Comfort Study
Lead Sponsor:
Epstein, Arthur B., OD, FAAO
Collaborating Sponsors:
Johnson & Johnson Vision Care, Inc.
Conditions:
Meibomian Gland Dysfunction
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study was designed to compare patient acceptance, comfort, and preference between two meibomian gland clearing devices (Lipiflow vs, iLux). Primary Objective was to compare patient comfort as ass...
Detailed Description
Introduction Meibomian gland disease (MGD) is increasingly recognized as a primary cause or contributor to tear instability and dry eye disease. Effective management of this disorder often requires me...
Eligibility Criteria
Inclusion
- Subject can be of any gender or race
- Subject must be 18 years of age or older at the time of informed consent
- 2\. Subject must be able to understand and must sign an Informed Consent that has been approved by an IRB 3. Subject must have confirmed diagnosis of Meibomian Gland Dysfunction 4. Subject must agree to not wear contact lenses the day of the Study visit
Exclusion
- History of intraocular or oculoplastic surgery within 6 months of Screening visit
- History of ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the Screening visit
- Active ocular infection or active ocular inflammation (including allergic conjunctivitis, vernal or giant papillary conjunctivitis) at time of Screening visit
- History of ocular surface abnormality that may compromise corneal integrity
- History of treatment with LipiFlow or iLux in either eye in the last 6 months
- Allergy to topical proparacaine eye drops
Key Trial Info
Start Date :
January 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2020
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04454983
Start Date
January 11 2020
End Date
February 29 2020
Last Update
August 19 2020
Active Locations (1)
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1
Phoenix Eye Care
Phoenix, Arizona, United States, 85032