Photobiomodulation With REd vs BluE Light (REBEL)

Phase

N/A

Condition

Dry Eyes

Blepharitis

Dry Eye Disease

Treatment

Sham Blue LLLT

Red LLLT

Blue LLLT

Clinical Study ID

NCT06371300

HLS21156

Ages > 18
All Genders

Study 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

Inclusion Criteria:

Individuals with dry eye disease symptoms (Ocular Surface Disease Indexquestionnaire (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 orocular surface damage measured using special dyes placed on the front surface of theeyes that temporarily stains any aggravated or damaged cells: > 5 corneal spots, > 9conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width)
Individuals need to also have Meibomian gland dysfunction. The diagnosis ofMeibomian gland dysfunction depends on how many of 5 glands in the central lowereyelid can express oil, and the quality of the oil. A diagnosis is made if there isdecreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality ofoil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oilglands grade 1 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will alsojustify a diagnosis of Meibomian gland dysfunction.
Individuals will also need to have ocular demodicosis, diagnosed by clinicalobservation on slit lamp biomicroscope based on signs including collarettes aroundthe base of lashes, visible Demodex tails, or excessive pouting of lash follicles inthose with good lid hygiene where Demodex was confirmed by secondary means such asvisible 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 monthafter final treatment

Exclusion

Exclusion Criteria:

Pregnancy
Ocular light-based therapies including intense pulsed light (IPL) or LLLT treatmentwithin the past 1 month or during study period in addition to those provided in thestudy
Contact lens wear in the past 2 weeks or during study period
Other active ocular surface diseases or history of ocular surgery or cornealinfections the past 6 months

Study Design

Sham Blue LLLT

May 01, 2024

December 30, 2026

Study Description

This study will be a randomized, double-masked, exploratory clinical study to assess the potential difference in impact between the two wavelengths used for LLLT. The whole study involves a total of 4 visits (consisting of 3 treatment visits, and 1 follow-up visit). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.

Connect with a study center

University of Auckland
Auckland 2193733,
New Zealand
Active - Recruiting
Aston Dry Eye Clinic
Birmingham 2655603, West Midlands B4 7ET
United Kingdom
Completed

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