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NCT03055897 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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