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Photobiomodulation With REd vs BluE Light (REBEL)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Aug 2025 to Oct 30, 2026v5 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Study completion date: Dec 2025 to Dec 30, 2026
    • Secondary endpoints revised (20)
  2. Minor Site contact updatedv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2024 to May 1, 2024
    • Secondary endpoints: 19 to 20
    • Site details revised
    v3
  4. Minor Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 4 of 19 entries
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06371300
Lead Sponsor Aston University
Conditions
(from sponsor)
Dry Eye Syndromes, Meibomian Gland Dysfunction, Blepharitis
Related terms Blepharitis, Dry Eye Syndromes, Meibomian Gland Dysfunction
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov