Tear Film Innovations iLux Safety Study

Not Applicable

Completed

• Conditions: Evaporative Dry Eye; Meibomian Gland Dysfunction
• Interventions: Device: iLux 2020 System

• Registration Number: NCT03055897
• Lead Sponsor: Tear Film Innovations, Inc.

Brief 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.

Study Timeline

• Study Start: 2016-05-03
• Primary Completion: 2016-05-17
• Study Completion: 2016-05-18
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Status Verified: 2020-11
• Results First Submitted: 2020-11-18
• Results First Submitted QC: 2020-11-18
• Results First Posted: 2020-12-16
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iLux 2020 System	iLux 2020 System	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual

Primary Outcome Measures

Name	Time	Method
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment	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.

Trial Locations

Locations (1)

TearFilm Innovations Investigative Site; 🇺🇸 Encinitas, California, United States