Tear Film Innovations iLux Safety Study

Meibomian Gland Dysfunction Clinical Trial

Official title:

Tear Film Innovations iLux Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055897
• Other study ID #: 2020-02
• Status: Completed
• Phase: N/A
• Start date: May 3, 2016
• Est. completion date: May 18, 2016

Study information

• Verified date: November 2020
• Source: Tear Film Innovations, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 18, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye
• Meibomian Gland Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	TearFilm Innovations Investigative Site	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Tear Film Innovations, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue 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.	Day 0 immediately post-treatment