Comparing red and blue light therapy for dry eye conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.