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Lipiflow vs iLux Patient Acceptance and Comfort Study

CompletedNA

Sponsor: Epstein, Arthur B., OD, FAAO

Conditions: Meibomian Gland Dysfunction, Dry Eye

Interventions: Lipiflow Thermal Pulsation System, iLux System

Countries: United States

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 assessed by Likert-style scale questionnaire following each bilateral procedure. Secondary Objective was to compare overall experience and treatment preference as assessed by Likert-style questionnaire following each bilateral procedure. Both devices are exempt from IDE regulations \[21 CFR 812.2(c)\].

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Subject can be of any gender or race
2. 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 Criteria:

1. History of intraocular or oculoplastic surgery within 6 months of Screening visit
2. History of ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the Screening visit
3. Active ocular infection or active ocular inflammation (including allergic conjunctivitis, vernal or giant papillary conjunctivitis) at time of Screening visit
4. History of ocular surface abnormality that may compromise corneal integrity
5. History of treatment with LipiFlow or iLux in either eye in the last 6 months
6. Allergy to topical proparacaine eye drops

Locations (1)

Phoenix, Arizona, United States