NCT03055897

Tear Film Innovations iLux Safety Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tear Film Innovations, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.

Detailed description

Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Conditions

• Meibomian Gland Dysfunction
• Evaporative Dry Eye

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

Timeline

• Start date: 2016-05-03
• Primary completion: 2016-05-17
• Completion: 2016-05-18
• First posted: 2017-02-16
• Last updated: 2023-04-12
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study