Tear Film Innovations iLux Safety Study

April 10, 2023 updated by: Tear Film Innovations, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92924
        • TearFilm Innovations Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 immediately post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tear Film Innovations, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2016

Primary Completion (Actual)

May 17, 2016

Study Completion (Actual)

May 18, 2016

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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