Comparing red and blue light therapy for dry eye conditions
Photobiomodulation of the Ocular Surface and Eyelids With Different Wavelengths: REd vs BluE Light (REBEL)
This study is testing whether red or blue light therapy can help people with dry eye conditions feel better and improve their eye health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aston University Academic / other |
| Locations | 2 sites (Auckland and 1 other locations) |
| Trial ID | NCT06371300 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the effects of photobiomodulation using red and blue light therapy on patients suffering from dry eye syndromes, meibomian gland dysfunction, and blepharitis. It is a randomized, double-masked study that will involve four visits to the Aston Dry Eye Clinic, where participants will receive either red LLLT, blue LLLT, or sham treatments. The study seeks to determine the differential impacts of these wavelengths on ocular symptoms and tear film stability, addressing a gap in current research on light therapy for eye conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals with diagnosed dry eye disease and meibomian gland dysfunction who meet specific symptom and diagnostic criteria.
Not a fit: Patients without dry eye symptoms or those who do not have meibomian gland dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into effective treatments for chronic dry eye conditions, potentially improving patient comfort and quality of life.
How similar studies have performed: While there is emerging evidence supporting the use of photobiomodulation in ophthalmology, this specific comparison of red versus blue light therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Auckland and 1 other locations
- University of Auckland — Auckland, New Zealand (Recruiting)
- Aston Dry Eye Clinic — Birmingham, West Midlands, United Kingdom (Completed)
Study contacts
- Study coordinator: James S Wolffsohn, PhD
- Email: j.chiang@aston.ac.uk
- Phone: +441212044400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.