Tear Film Innovations iLux Safety Study

• Sponsor: Tear Film Innovations, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03055897
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Days): 15
• Patients Per Site Per Month: 30.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction; Evaporative Dry Eye	Device: iLux 2020 System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tear Film Innovations iLux Safety Study
• Actual Study Start Date: May 3, 2016
• Actual Primary Completion Date: May 17, 2016
• Actual Study Completion Date: May 18, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TearFilm Innovations Investigative Site	Encinitas	California	United States	92924

Sponsors and Collaborators

• Tear Film Innovations, Inc.

Investigators

• Study Director: Sr. CDMA Project Lead, CDMA Ocular Health, Alcon Research, LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2016

More Information

Publications

None provided.

• Responsible Party: Tear Film Innovations, Inc.
• ClinicalTrials.gov Identifier: NCT03055897
• Other Study ID Numbers: 2020-02
• First Posted: Feb 16, 2017
• Last Update Posted: Dec 16, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dry Eye Syndromes; Meibomian Gland Dysfunction

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one investigative site located in the United States.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Period Title: Overall Study
STARTED	15
COMPLETED	15
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (15.1)
Sex/Gender, Customized (participants) [Number]
Male	7 46.7%
Not reported	8 53.3%
Race/Ethnicity, Customized (participants) [Number]
Hispanic/Latino	1 6.7%
White	11 73.3%
Not Reported	3 20%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set: All subjects enrolled and treated

Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Measure Participants	15
Measure eyes	30
Corneal temperature	37.7 (0.5)
Eyelid temperature	38.5 (0.8)
Surface temperature	38.2 (0.7)

Adverse Events

Time Frame	Adverse event data was collected for each participant from time of enrollment until time of study exit, approximately 2 days.
Adverse Event Reporting Description	An adverse event was defined as any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. All participants exposed to the study treatment were evaluated for adverse events.
Arm/Group Title	iLux 2020 System
Arm/Group Description	Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
All Cause Mortality
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	iLux 2020 System
	Affected / at Risk (%)	# Events
Total	0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.