Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 299
- Locations
- 30
- Primary Endpoint
- Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Study Overview
Brief Summary
The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
Detailed Description
Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 12.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Understand and sign an Informed Consent document;
- •Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
- •Agree not to wear contact lenses for the duration of the study;
- •Other protocol-specified inclusion criteria may apply.
- •Exclusion Criteria
- •History of eye surgery, as specified in the protocol;
- •Eye infection or inflammation, as specified in the protocol;
- •Eyelid abnormalities; eyelid tattoos;
- •Treated with LipiFlow or iLux in either eye in the last 12 months;
- •Contact lens wear within the 1 month prior to Screening;
- •Other protocol-specified exclusion criteria may apply.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
Time Frame: Baseline, Month 12
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
Secondary Outcomes
No secondary outcomes reported