Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease

• ClinicalTrials.gov Identifier: NCT03658811
• Recruitment Status: Completed
• First Posted: September 5, 2018
• Results First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Sponsor: Toyos Clinic
• Information provided by (Responsible Party): Toyos Clinic

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Dry Eye
• Intervention: Device: intense pulsed light
• Enrollment: 19

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Period Title: Overall Study
Started	19
Completed	16
Not Completed	3
Reason Not Completed
Lost to Follow-up	3

Baseline Characteristics

Arm/Group Title		Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description		Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Overall Number of Baseline Participants		19
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	13 68.4%
	>=65 years	6 31.6%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	19 participants
		64.05; (49 to 86)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants
	Female	15 78.9%
	Male	4 21.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	19 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	19 participants
		19

Outcome Measures

1. Primary Outcome

Title	Non-invasive Tear Break up Time (TBUT)
Description	average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description:	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Overall Number of Participants Analyzed	19
Mean (95% Confidence Interval); Unit of Measure: seconds
TBUT OD (right eye)	3.9; (2.6 to 5.3)
TBUT OS (left eye)	4.0; (2.6 to 5.4)

2. Secondary Outcome

Title	Measure of Visual Analog Scale Pain Over Last 24 Hours
Description	measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description:	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: millimeters
	65.42 (0.01)

3. Secondary Outcome

Title	Ocular Discomfort Frequency Assessment on Visual Analog Scale
Description	scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description:	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: millimeters
	28.27 (0.01)

4. Secondary Outcome

Title	Measure of Visual Analog Scale Pain
Description	measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description:	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: millimeters
	26.93 (0.01)

Adverse Events

Time Frame	Adverse events were noted during patients enrollment in the study, at minimum 8 weeks and at most 16 weeks.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Upper Eyelid Meibomian Gland Dysfunction
Arm/Group Description	Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
All-Cause Mortality
	Upper Eyelid Meibomian Gland Dysfunction
	Affected / at Risk (%)
Total	0/19 (0.00%)
Serious Adverse Events
	Upper Eyelid Meibomian Gland Dysfunction
	Affected / at Risk (%)	# Events
Total	0/19 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Upper Eyelid Meibomian Gland Dysfunction
	Affected / at Risk (%)	# Events
Total	13/19 (68.42%)
Eye disorders
Mild Stinging * [1]	5/19 (26.32%)	5
Moderate discomfort * [2]	13/19 (68.42%)	13
* Indicates events were collected by non-systematic assessment; [1] Mild stinging from the light therapy on the upper eyelid; [2] Mild discomfort during digital Expression of upper eyelid

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dillon O'Brien
• Organization: Toyos Clinic
• Phone: 6153274015 ext 6
• EMail: dobrien@toyosclinic.com

• Responsible Party: Toyos Clinic
• ClinicalTrials.gov Identifier: NCT03658811
• Other Study ID Numbers: TCLum-001
• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Results First Submitted: December 6, 2018
• Results First Posted: February 12, 2019
• Last Update Posted: February 12, 2019