Back to resultsTear Film Innovations iLux Safety Study
Primary Purpose
Meibomian Gland Dysfunction, Evaporative Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iLux 2020 System
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
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
Sites / Locations
- TearFilm Innovations Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iLux 2020 System
Arm Description
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03055897
First Posted
February 10, 2017
Last Updated
April 10, 2023
Sponsor
Tear Film Innovations, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03055897
Brief Title
Tear Film Innovations iLux Safety Study
Official Title
Tear Film Innovations iLux Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
May 17, 2016 (Actual)
Study Completion Date
May 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tear Film Innovations, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Evaporative Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iLux 2020 System
Arm Type
Experimental
Arm Description
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Intervention Type
Device
Intervention Name(s)
iLux 2020 System
Intervention Description
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
Primary Outcome Measure Information:
Title
Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
Description
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.
Time Frame
Day 0 immediately post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. CDMA Project Lead, CDMA Ocular Health
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
TearFilm Innovations Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92924
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tear Film Innovations iLux Safety Study
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