Tear Film Innovations iLux Safety Study

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.

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Syndromes Evaporative Dry Eye Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TearFilm Innovations Investigative Site

Encinitas, California, 92924, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Sign written informed consent prior to study participation

Key Exclusion Criteria:

History of ocular surgery within 1 year
Active ocular infection
Ocular surface abnormality; lid surface abnormalities
Pregnant, nursing or not utilizing adequate birth control measures
Other protocol-specified exclusion criteria may apply

Treatment and study plan

iLux 2020 System

Device

Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands

Primary outcomes

Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment

Time frame: Day 0 immediately post-treatment

Post-heating values were obtained by infrared camera for each participant. The cornea, the eyelid, and the surface tissue surrounding the eye were measured. Both eyes contributed to the analysis. No formal hypothesis testing was specified.

Sponsors and collaborators

Lead sponsor

Tear Film Innovations, Inc.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Feb 16, 2017
Registry last updated: Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed