Mechanisms of Light-based Therapies for Dry Eye Disease

NCT06004895 | Completed Results

• 1 other identifier: HLS21118
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye disease is a common condition affecting millions worldwide and costing millions in healthcare due to reduced work productivity and quality of life. The disruption of oil glands in our eyelids known as Meibomian glands, which produce the oily layer of our tears to protect it from evaporating, is one of the most common contributors of dry eye disease. Much effort has been put into developing effective treatments for this condition as new treatments are constantly being introduced to the market. The purpose of this clinical trial is to investigate how proven light-based therapies work in treating dry eye disease and oil gland disruption. These therapies include intense-pulsed light therapy (IPL) which uses a series of light flashes on the facial skin surface, and low-level light therapy (LLLT) which uses a mask with a series of light-emitting diodes (LEDs) to warm the body cells. The main questions it aims to answer are:

1. 1.What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes?
2. 2.Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption?

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Keywords

Intense pulsed light therapy; Low-level light therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session

  Measure of the stability of tears and how fast the tears evaporate in seconds using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.

  Baseline and 3 months after final treatment session (up to 6 months after Baseline)

Secondary Outcomes (24)

• Change From Baseline in Ocular Surface Disease Index Scores to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in 5-Item Dry Eye Questionnaire Scores to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in Tear Meniscus Height to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in Lipid Layer Pattern Grading to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

Other Outcomes (6)

• Change From Baseline in Blood Perfusion of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in Microvasculature Blood Oxygen Saturation of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

• Change From Baseline in Relative Erythrocyte Fraction Volume of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session

  Baseline up to 3 months after final treatment session (up to 6 months after Baseline)

Study Arms (2)

Actual IPL and LLLT

EXPERIMENTAL

IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.

Device: Actual IPL; Device: LLLT

Sham IPL and LLLT

SHAM COMPARATOR

Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.

Device: Sham IPL; Device: LLLT

Interventions

LLLT DEVICE

Mask with LEDs transferring a total of about 32 J/cm\^2 of energy to facial and eyelids region with their eyes closed

Actual IPL and LLLT; Sham IPL and LLLT

Actual IPL DEVICE

Five light pulses along lower lid region of one eye of the participant ranging from 59 to 69 Joules (J) over an area of 2.5cm by 4.5cm for each pulse

Actual IPL and LLLT

Sham IPL DEVICE

Simulated five light pulses along lower lid region of the other eye of the same participant

Sham IPL and LLLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) (Wolffsohn et al., 2017)
• 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 2 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction
• Age ≥ 18 years, male or female
• Able to provide written consent in English
• Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment

You may not qualify if:

• Pregnancy
• Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period)
• Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study
• Use of topical medical eyedrops in the past 3 months or during study period
• Contact lens wear in the past 2 weeks or during study period
• Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome
• Other active ocular surface diseases or history of ocular surgery or corneal infections
• Individuals with 1 eye

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

Aston Dry Eye Clinic

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

Related Publications (6)

• Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.

  PMID: 21450918 BACKGROUND

• Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.

  PMID: 23108007 BACKGROUND

• Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.

  PMID: 28736342 BACKGROUND

• Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

  PMID: 10815152 BACKGROUND

• Chalmers RL, Begley CG, Caffery B. Validation of the 5-Item Dry Eye Questionnaire (DEQ-5): Discrimination across self-assessed severity and aqueous tear deficient dry eye diagnoses. Cont Lens Anterior Eye. 2010 Apr;33(2):55-60. doi: 10.1016/j.clae.2009.12.010. Epub 2010 Jan 25.

  PMID: 20093066 BACKGROUND

• Arita R, Minoura I, Morishige N, Shirakawa R, Fukuoka S, Asai K, Goto T, Imanaka T, Nakamura M. Development of Definitive and Reliable Grading Scales for Meibomian Gland Dysfunction. Am J Ophthalmol. 2016 Sep;169:125-137. doi: 10.1016/j.ajo.2016.06.025. Epub 2016 Jun 23.

  PMID: 27345733 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Professor James S Wolffsohn
• Organization: Aston University

j.s.w.wolffsohn@aston.ac.uk

07833049245

Study Officials

• James S Wolffsohn, PhD

  Aston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One eye of the participant is randomised to receiving IPL and LLLT, while the other eye of the same participant will receive sham intense pulsed light therapy and low-level light therapy.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: October 25, 2023
• Primary Completion: November 29, 2024
• Study Completion: December 30, 2025
• Last Updated: February 5, 2026
• Results First Posted: July 23, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified datasets will be available upon request.
• Access Criteria: Deidentified datasets will be available upon request.

Locations

GB (1)