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

NCT03658811 | Completed Results FDA Device

• 1 other identifier: TCLum-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

meibomian gland dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (3)

• Measure of Visual Analog Scale Pain Over Last 24 Hours

  24 hours

• Ocular Discomfort Frequency Assessment on Visual Analog Scale

  24 hours

• Measure of Visual Analog Scale Pain

  2 weeks

Study Arms (1)

Upper eyelid meibomian gland dysfunction

EXPERIMENTAL

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

Device: intense pulsed light

Interventions

intense pulsed light DEVICE

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

Upper eyelid meibomian gland dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Dillon O'Brien
• Organization: Toyos Clinic

dobrien@toyosclinic.com

6153274015

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: September 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 31, 2018
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2018-12

Locations

US (1)