Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06371300

Photobiomodulation With REd vs BluE Light (REBEL)

Led by Aston University · Updated on 2026-01-21

36

Participants Needed

2

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids). Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group.

CONDITIONS

Official Title

Photobiomodulation With REd vs BluE Light (REBEL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with dry eye disease symptoms (OSDI score  13 or DEQ5 score > 6) and signs (tear film instability with non-invasive tear break-up time < 10 seconds or ocular surface damage with specific staining criteria)
  • Diagnosis of Meibomian gland dysfunction based on reduced oil gland expressibility and quality or gland blockage/loss
  • Presence of ocular demodicosis confirmed by clinical signs such as collarettes or visible Demodex tails
  • Age 18 years or older, any gender
  • Able to provide written consent in English
  • Able to attend 4 visits: 3 treatments and 1 follow-up visit 1 month after final treatment
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Light-based eye treatments like intense pulsed light or LLLT within 1 month before or during the study besides study treatments
  • Contact lens wear within 2 weeks before or during the study
  • Other active eye surface diseases or history of eye surgery or corneal infection within past 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Auckland

Auckland, New Zealand

Actively Recruiting

2

Aston Dry Eye Clinic

Birmingham, West Midlands, United Kingdom, B4 7ET

Completed

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Research Team

J

James S Wolffsohn, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Photobiomodulation With REd vs BluE Light (REBEL) | DecenTrialz