Dry Eye SyndromesMOLTNCT06004895
Mechanisms of Light-based Therapies for Dry Eye Disease
A study testing Actual IPL and LLLT in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Aston University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Actual IPL and LLLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aston Dry Eye Clinic
Birmingham, West Midlands, B4 7ET
About this study
Official title: Mechanisms of Action of Light-based Therapies in the Management of Dry Eye Disease and Meibomian Gland Dysfunction
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:
Read more
- What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes?
- Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption?
Participants with dry eye disease and oil gland disruption will receive four treatments with these light-based therapies each separated by two to three weeks apart, and followed up two to three weeks and three months after the final treatment session. One eye of the participant will receive intense pulsed light together with low-level light therapy, while the other eye will receive only low-level light therapy with a sham intense pulsed light treatment so that the researchers can compare if clinical signs and symptoms improve in one eye more than the other.
Read the detailed description
This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomized to receive either IPL+LLLT or sham IPL+LLLT. The whole study involves a total of 6 visits (consisting of 4 treatment visits, and 2 follow-up visits). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Actual IPL, Sham IPL, LLLT
- Keywords
- Intense pulsed light therapy, Low-level light therapy
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actual IPLDevice
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
Sham IPLDevice
Simulated five light pulses along lower lid region of the other eye of the same participant
LLLTDevice
Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham IPL; Device: LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
Measured: 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
Validated questionnaire for assessing dry eye symptom severity and frequency. Scores range from 0 indicating no dry eye symptoms to 22 with severe dry eye symptoms (Chalmers et al, 2010).
Measured: 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
Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
Measured: 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
Subjective grading of the appearance of the lipid layer pattern as a surrogate measure of its thickness using the Oculus Keratograph 5M instrument. This ranges from Grade 1 indicating very thin lipid layer to Grade 6 indicating very thick lipid layer.
Measured: 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
Automated objective grading of the bulbar conjunctival redness using the Oculus Keratograph 5M instrument. This ranges from Grade 0 indicating no redness to Grade 4 indicating substantial redness.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Blinks to the Final Follow-up 3 Months After Final Treatment Session
Manual subjective count of the number of total blinks using the Oculus Keratograph 5M instrument.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session
Subjective measure of visual acuity using Logarithm of the Minimum Angle Resolution (logMAR) scoring, ranging from -0.30 which signify the ability to be able to resolve the smallest letters, to 1.00 which signify the ability to resolve only the largest letters.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of corneal staining using fluorescein instillation, cobalt blue light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of bulbar conjunctival staining using lissamine green instillation, white light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of lid wiper epitheliopathy using lissamine green instillation and white light illumination. This grading ranges from 0 with no lid wiper epitheliopathy to 4 with severe lid wiper epitheliopathy
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lower Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session
Subjective assessment of the amount of Demodex present at the base of the lashes using slit lamp biomicroscopy and white light illumination (Muntz et al, 2020).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session
Subjective assessment of the number of blocked or capped Meibomian Glands using slit lamp biomicroscopy and white light illumination.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of telangiectasia at the lid margins using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with no telangiectasia to 3 with severe telangiectasia (Arita et al, 2016).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of meibum expressibility of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with all glands being expressible to 3 with no glands being expressible (Tomlinson et al, 2011).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of meibum quality of lower eyelids using slit lamp biomicroscopy and white light illumination. This grading ranges from 0 with clear fluid being expressed to 3 with inspissated toothpaste-like expression (Tomlinson et al, 2011).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Central Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
Measure of total corneal nerve length of sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy. The nerve length is measured using a semi-automated procedure (NeuronJ plugin on ImageJ software) which measures the total length of the corneal nerves in a single frame (400 microns by 400 microns) of corneal confocal microscopy. This is then averaged across three distinct central corneal nerve frame to generate the total central corneal nerve length measure.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Inferior Whorl Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
Measure of total inferior whorl length of sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy. The nerve length is measured using a semi-automated procedure (NeuronJ plugin on ImageJ software) which measures the total length of the corneal nerves in a single frame (400 microns by 400 microns) of corneal confocal microscopy. This is conducted for a single frame of the inferior whorl, which is a identifiable landmark where the corneal nerves traverse towards.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Putative Tissue-Resident Memory T-Cell Density to the Final Follow-up 3 Months After Final Treatment Session
Measure of memory T-cell density from sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Frequency Scores to the Final Follow-up 3 Months After Final Treatment Session
Validated questionnaire for assessing dry eye symptom severity and frequency. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Severity Scores to the Final Follow-up 3 Months After Final Treatment Session
Validated questionnaire for assessing dry eye symptom severity and frequency. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Partial Blinks to the Final Follow-up 3 Months After Final Treatment Session
Manual subjective count of the number of partial blinks using the Oculus Keratograph 5M instrument.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Upper Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Putative Dendritic Cell Density to the Final Follow-up 3 Months After Final Treatment Session
Measure of dendritic cell density from sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
Measured: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start25 Oct 2023
- Primary completion29 Nov 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Chiang, Aston University
- Investigators
- James S Wolffsohn, PhD, Study director, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004895
- Sponsor's protocol ID
- HLS21118
- Acronym
- MOLT
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2023
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified datasets will be available upon request.
Publications
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.
PubMed 21450918Pult 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.
PubMed 23108007Wolffsohn 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.
PubMed 28736342Schiffman 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.
PubMed 10815152Chalmers 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.
PubMed 20093066Arita 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.
PubMed 27345733Chiang JCB, Dremin V, Semp DA, Lam HY, Ting PW, Ayaz M, Wolffsohn JS. Low-level light therapy alone versus combination therapy with intense pulsed light in the treatment of dry eye disease with meibomian gland dysfunction: A randomised paired-eye and mechanism of action trial. Cont Lens Anterior Eye. 2025 Dec;48(6):102456. doi: 10.1016/j.clae.2025.102456. Epub 2025 Jun 9.
PubMed 40494722
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action of Light-based Therapies in the Management of Dry Eye Disease and Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT06004895
- Acronym / sponsor ID
- MOLT / HLS21118
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- Intense pulsed light therapy, Low-level light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes?
- Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption?
Participants with dry eye disease and oil gland disruption will receive four treatments with these light-based therapies each separated by two to three weeks apart, and followed up two to three weeks and three months after the final treatment session. One eye of the participant will receive intense pulsed light together with low-level light therapy, while the other eye will receive only low-level light therapy with a sham intense pulsed light treatment so that the researchers can compare if clinical signs and symptoms improve in one eye more than the other.
Detailed description
This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomized to receive either IPL+LLLT or sham IPL+LLLT. The whole study involves a total of 6 visits (consisting of 4 treatment visits, and 2 follow-up visits). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Actual IPL and LLLT | Experimental | Device: Actual IPL, Device: LLLTIPL 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. |
| Sham IPL and LLLT | Sham comparator | Device: Sham IPL, Device: LLLTSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actual IPLFive 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 | Device | Actual IPL and LLLT |
| Sham IPLSimulated five light pulses along lower lid region of the other eye of the same participant | Device | Sham IPL and LLLT |
| LLLTMask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed | Device | Actual IPL and LLLT, Sham IPL and LLLT |
Primary outcome
Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline and 3 months after final treatment session (up to 6 months after Baseline)
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.
24 secondary outcomes
Change From Baseline in Ocular Surface Disease Index Scores to the Final Follow-up 3 Months After Final Treatment Session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Blinks to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lower Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Central Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Total Inferior Whorl Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Putative Tissue-Resident Memory T-Cell Density to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Frequency Scores to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Severity Scores to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Partial Blinks to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Upper Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Change From Baseline in Putative Dendritic Cell Density to the Final Follow-up 3 Months After Final Treatment Session
Time frame: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21450918Tomlinson 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.
- Background: PubMed 23108007Pult 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.
- Background: PubMed 28736342Wolffsohn 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.
- Background: PubMed 10815152Schiffman 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.
- Background: PubMed 20093066Chalmers 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.
- Background: PubMed 27345733Arita 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.
- Derived from this study: PubMed 40494722Chiang JCB, Dremin V, Semp DA, Lam HY, Ting PW, Ayaz M, Wolffsohn JS. Low-level light therapy alone versus combination therapy with intense pulsed light in the treatment of dry eye disease with meibomian gland dysfunction: A randomised paired-eye and mechanism of action trial. Cont Lens Anterior Eye. 2025 Dec;48(6):102456. doi: 10.1016/j.clae.2025.102456. Epub 2025 Jun 9.
- Individual participant dataSharing planned: Yes. Deidentified datasets will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James S Wolffsohn, PhD study director
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actual IPL and LLLT in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Aston University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session (time frame: Baseline and 3 months after final treatment session (up to 6 months after Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06004895, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.