Trial Outcomes & Findings for Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease (NCT NCT03658811)

NCT ID: NCT03658811

Last Updated: 2019-02-12

Results Overview

average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-02-12

Participant Flow

Participant milestones

Measure	Upper Eyelid Meibomian Gland Dysfunction 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 Study STARTED	19
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Upper Eyelid Meibomian Gland Dysfunction 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 Study Lost to Follow-up

3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Upper Eyelid Meibomian Gland Dysfunction n=19 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	64.05 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up

Outcome measures

Measure	Upper Eyelid Meibomian Gland Dysfunction n=19 Participants 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
Non-invasive Tear Break up Time (TBUT) TBUT OD (right eye)	3.9 seconds Interval 2.6 to 5.3
Non-invasive Tear Break up Time (TBUT) TBUT OS (left eye)	4.0 seconds Interval 2.6 to 5.4

SECONDARY outcome

Timeframe: 24 hours

measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)

Outcome measures

Measure

Upper Eyelid Meibomian Gland Dysfunction n=19 Participants 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

Measure of Visual Analog Scale Pain Over Last 24 Hours

65.42 millimeters Standard Deviation 0.01

SECONDARY outcome

Timeframe: 24 hours

scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes

Outcome measures

Measure

Upper Eyelid Meibomian Gland Dysfunction n=19 Participants 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

Ocular Discomfort Frequency Assessment on Visual Analog Scale

28.27 millimeters Standard Deviation 0.01

SECONDARY outcome

Timeframe: 2 weeks

measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)

Outcome measures

Measure

Upper Eyelid Meibomian Gland Dysfunction n=19 Participants 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

Measure of Visual Analog Scale Pain

26.93 millimeters Standard Deviation 0.01

Adverse Events

Upper Eyelid Meibomian Gland Dysfunction

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Upper Eyelid Meibomian Gland Dysfunction n=19 participants at risk 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
Eye disorders Mild Stinging	26.3% 5/19 • Number of events 5 • Adverse events were noted during patients enrollment in the study, at minimum 8 weeks and at most 16 weeks.
Eye disorders Moderate discomfort	68.4% 13/19 • Number of events 13 • Adverse events were noted during patients enrollment in the study, at minimum 8 weeks and at most 16 weeks.

Additional Information

Dillon O'Brien

Toyos Clinic

Phone: 6153274015

Email: dobrien@toyosclinic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place