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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03956225
Other study ID # DEG723-P001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2019
Est. completion date October 24, 2020

Study information

Verified date September 2021
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Systane iLux® Dry Eye System
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
LipiFlow® Thermal Pulsation System
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

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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