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

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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:
Information provided by (Responsible Party):
Toyos Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dry Eye
Intervention Device: intense pulsed light
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
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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
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
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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
Hide 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
1.Primary Outcome
Title Non-invasive Tear Break up Time (TBUT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Eyelid Meibomian Gland Dysfunction
Hide 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)
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
Hide 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%)    
Show Serious Adverse Events Hide Serious Adverse Events
Upper Eyelid Meibomian Gland Dysfunction
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dillon O'Brien
Organization: Toyos Clinic
Phone: 6153274015 ext 6
EMail: dobrien@toyosclinic.com
Layout table for additonal information
Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03658811     History of Changes
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