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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Device: intense pulsed light

• Registration Number: NCT03658811
• Lead Sponsor: Toyos Clinic

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.

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-31
• Study Start: 2018-09-01
• Study First Posted: 2018-09-05
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-31
• Status Verified: 2018-12
• Results First Submitted: 2018-12-06
• Results First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Results First Posted: 2019-02-12
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper eyelid meibomian gland dysfunction	intense pulsed light	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

Primary Outcome Measures

Name	Time	Method
Non-invasive Tear Break up Time (TBUT)	2 weeks	average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up

Secondary Outcome Measures

Name	Time	Method
Measure of Visual Analog Scale Pain	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)
Measure of Visual Analog Scale Pain Over Last 24 Hours	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	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

Trial Locations

Locations (1)

Toyos Clinic; 🇺🇸 Nashville, Tennessee, United States