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

Primary Purpose

Dry Eye

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

intense pulsed light

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring meibomian gland dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

subjects older than 18
cloudy or inspissated meibomian glands in both upper lids
ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride.

Exclusion Criteria:

Patients with eyelid abnormalities
intense pulsed light treatment within the past year.
Patients on oral retinoids,
patients undergoing intraocular surgery within the past year,
patients with uncontrolled ocular disease,
Fitzpatrick skin type V or VI,
neuro-paralysis in the planned treatment area in the past 6 months,
pre-cancerous lesions in the planned treatment area.
New topical eye treatments,
previous expression of meibomian glands,
legally blind in one eye.

Sites / Locations

Toyos Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Upper eyelid meibomian gland dysfunction

Arm 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

Outcomes

Primary Outcome Measures

Non-invasive Tear Break up Time (TBUT)

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

Secondary Outcome Measures

Measure of Visual Analog Scale Pain Over Last 24 Hours

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

Ocular Discomfort Frequency Assessment on Visual Analog Scale

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

Measure of Visual Analog Scale Pain

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

Full Information

NCT ID

NCT03658811

First Posted

August 29, 2018

Last Updated

January 23, 2019

Sponsor

Toyos Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03658811

Brief Title

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

Official Title

Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

October 30, 2018 (Actual)

Study Completion Date

October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toyos Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

Upper eyelid treatment has not been used with previously described methods of treatment of dry eye disease using intense pulsed light therapy because the upper lids disease was typically not as advanced as lower lid and because direct treatment of the upper lid was not felt to be necessary as each light pulse extended over the entire periorbita even when concentrated on the lower lid.

Detailed Description

Dry eye disease is an under-diagnosed and growing problem. Intense pulsed light has been a proven method of improving the signs and symptoms of meibomian gland dysfunction including lid margin vascularity, meibum viscosity, OSDI mean score and tear break up. This study looks at the safety and effect of treatment of upper lids only to evaluate the safety and efficacy of direct upper lid treatment on the signs and symptoms of dry eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

meibomian gland dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patient were enrolled in the study if they had visible signs of upper lid meibomian gland dysfunction and persistent dry eye symptoms and pain despite treatment with conservative dry eye therapies.

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upper eyelid meibomian gland dysfunction

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

intense pulsed light

Intervention Description

Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subjects older than 18 cloudy or inspissated meibomian glands in both upper lids ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride. Exclusion Criteria: Patients with eyelid abnormalities intense pulsed light treatment within the past year. Patients on oral retinoids, patients undergoing intraocular surgery within the past year, patients with uncontrolled ocular disease, Fitzpatrick skin type V or VI, neuro-paralysis in the planned treatment area in the past 6 months, pre-cancerous lesions in the planned treatment area. New topical eye treatments, previous expression of meibomian glands, legally blind in one eye.

Facility Information:

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Excel spreadsheet with data but no identifying characteristics could be shared.

Learn more about this trial

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

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