Tear Film Innovations iLux Safety Study
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2016
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedApril 12, 2023
November 1, 2020
14 days
February 10, 2017
November 18, 2020
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
iLux 2020 System
EXPERIMENTALMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Interventions
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
Eligibility Criteria
You may qualify if:
- \- Sign written informed consent prior to study participation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TearFilm Innovations Investigative Site
Encinitas, California, 92924, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior CDMA Project Lead, CDMA Ocular Health
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Sr. CDMA Project Lead, CDMA Ocular Health
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 16, 2017
Study Start
May 3, 2016
Primary Completion
May 17, 2016
Study Completion
May 18, 2016
Last Updated
April 12, 2023
Results First Posted
December 16, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share