NCT06371300 Photobiomodulation With REd vs BluE Light (REBEL)
| NCT ID | NCT06371300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aston University |
| Condition | Dry Eye Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-05-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score \> 6) and signs (tear film instability measured with non-invasive tear break-up time \< 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: \> 5 corneal spots, \> 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) * Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 1 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction. * Individuals will also need to have ocular demodicosis, diagnosed by clinical observation on slit lamp biomicroscope based on signs including collarettes around the base of lashes, visible Demodex tails, or excessive pouting of lash follicles in those with good lid hygiene where Demodex was confirmed by secondary means such as visible Demodex tails. * Age ≥ 18 years, male or female * Able to provide written consent in English * Able to attend a total of 4 visits: 3 treatment visits and followed up for 1 month after final treatment Exclusion Criteria: * Pregnancy * Ocular light-based therapies including intense pulsed light (IPL) or LLLT treatment within the past 1 month or during study period in addition to those provided in the study * Contact lens wear in the past 2 weeks or during study period * Other active ocular surface diseases or history of ocular surgery or corneal infections the past 6 months
Contact & Investigator
James S Wolffsohn, PhD
STUDY DIRECTOR
Aston University
Frequently Asked Questions
Who can join the NCT06371300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06371300 currently recruiting?
Yes, NCT06371300 is actively recruiting participants. Contact the research team at j.chiang@aston.ac.uk for enrollment information.
Where is the NCT06371300 trial being conducted?
This trial is being conducted at Auckland, New Zealand, Birmingham, United Kingdom.
Who is sponsoring the NCT06371300 clinical trial?
NCT06371300 is sponsored by Aston University. The principal investigator is James S Wolffsohn, PhD at Aston University. The trial plans to enroll 36 participants.