Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

Alcon

Status: Completed

Conditions: Evaporative Dry Eye Disease; Meibomian Gland Dysfunction

Treatments: Device: LipiFlow® Thermal Pulsation System; Device: Systane iLux® Dry Eye System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956225

DEG723-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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299 participants in 2 patient groups

iLux

Experimental group

Description:

Single treatment with the Systane iLux Dry Eye System and 12-month follow-up. Both eyes will be treated.

Treatment:

Device: Systane iLux® Dry Eye System

LipiFlow

Active Comparator group

Description:

Single treatment with the LipiFlow Thermal Pulsation System and 12-month follow-up. Both eyes will be treated.

Treatment:

Device: LipiFlow® Thermal Pulsation System