protocolSection identificationModule nctId: NCT06371300, orgStudyIdInfo id: HLS21156, briefTitle: Photobiomodulation With REd vs BluE Light (REBEL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Aston University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dry Eye Syndromes, conditions: Meibomian Gland Dysfunction, conditions: Blepharitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Each participant is randomised to either of 3 groups: Red light only group, red plus blue light group, or sham treatment group., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Red LLLT, interventions name: Blue LLLT, interventions name: Sham Red LLLT, interventions name: Sham Blue LLLT, outcomesModule primaryOutcomes measure: Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session, secondaryOutcomes measure: Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aston Dry Eye Clinic, city: Birmingham, state: West Midlands, zip: B4 7ET, country: United Kingdom, contacts name: Jeremy Chung Bo Chiang, PhD, role: CONTACT, phone: +441212043934, phoneExt: 3934, email: j.chiang@aston.ac.uk, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False