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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: intense pulsed light

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37027
      • Toyos Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: intense pulsed light; Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 hours
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	24 hours
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)	2 weeks

Collaborators and Investigators

• Sponsor: Toyos Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: meibomian gland dysfunction
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: TCLum-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Excel spreadsheet with data but no identifying characteristics could be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes