Meibomian Gland Dysfunction Clinical Trial
Official title:
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Verified date | September 2021 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 299 |
Est. completion date | October 24, 2020 |
Est. primary completion date | October 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Alcon Investigator 9082 | Chambersburg | Pennsylvania |
United States | Alcon Investigator 8046 | Granville | Ohio |
United States | Alcon Investigator 4782 | Highland Park | Illinois |
United States | Alcon Investigator 1455 | Kansas City | Missouri |
United States | Alcon Investigator 5163 | Kirkland | Washington |
United States | Alcon Investigator 9083 | Long Beach | California |
United States | Alcon Investigator 9081 | Los Angeles | California |
United States | Alcon Investigator 5582 | Louisville | Kentucky |
United States | Alcon Investigator 6402 | Medina | Minnesota |
United States | Alcon Investigator 5127 | Panama City | Florida |
United States | Alcon Investigator 6567 | Pittsburg | Kansas |
United States | Alcon Investigator 3828 | Poughkeepsie | New York |
United States | Alcon Investigator 6313 | Powell | Ohio |
United States | Alcon Investigator 9084 | San Diego | California |
United States | Alcon Investigator 8028 | Wichita Falls | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at 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. | Baseline, Month 12 |
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