NCT03055832

Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Tear Film Innovations, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.

Detailed description

At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	iLux 2020 System	Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
DEVICE	LipiFlow Pulsation System	Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Timeline

• Start date: 2017-02-09
• Primary completion: 2017-07-20
• Completion: 2017-07-20
• First posted: 2017-02-16
• Last updated: 2023-04-12
• Results posted: 2019-05-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study