Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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