NCT06004895

Mechanisms of Light-based Therapies for Dry Eye Disease

Mechanisms of Action of Light-based Therapies in the Management of Dry Eye Disease and Meibomian Gland Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Aston University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dry eye disease is a common condition affecting millions worldwide and costing millions in healthcare due to reduced work productivity and quality of life. The disruption of oil glands in our eyelids known as Meibomian glands, which produce the oily layer of our tears to protect it from evaporating, is one of the most common contributors of dry eye disease. Much effort has been put into developing effective treatments for this condition as new treatments are constantly being introduced to the market. The purpose of this clinical trial is to investigate how proven light-based therapies work in treating dry eye disease and oil gland disruption. These therapies include intense-pulsed light therapy (IPL) which uses a series of light flashes on the facial skin surface, and low-level light therapy (LLLT) which uses a mask with a series of light-emitting diodes (LEDs) to warm the body cells. The main questions it aims to answer are: 1. What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes? 2. Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption? Participants with dry eye disease and oil gland disruption will receive four treatments with these light-based therapies each separated by two to three weeks apart, and followed up two to three weeks and three months after the final treatment session. One eye of the participant will receive intense pulsed light together with low-level light therapy, while the other eye will receive only low-level light therapy with a sham intense pulsed light treatment so that the researchers can compare if clinical signs and symptoms improve in one eye more than the other.

Detailed description

This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomized to receive either IPL+LLLT or sham IPL+LLLT. The whole study involves a total of 6 visits (consisting of 4 treatment visits, and 2 follow-up visits). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.

Conditions

• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DEVICE	Actual IPL	Five light pulses along lower lid region of one eye of the participant ranging from 59 to 69 Joules (J) over an area of 2.5cm by 4.5cm for each pulse
DEVICE	Sham IPL	Simulated five light pulses along lower lid region of the other eye of the same participant
DEVICE	LLLT	Mask with LEDs transferring a total of about 32 J/cm\^2 of energy to facial and eyelids region with their eyes closed

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-11-29
• Completion: 2025-12-30
• First posted: 2023-08-22
• Last updated: 2026-02-05
• Results posted: 2025-07-23

Locations

1 site across 1 country: United Kingdom