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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Blood Perfusion of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of blood flow using laser doppler flowmetry instrument, with higher values indicating better perfusion. | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James S Wolffsohn, PhD | Aston University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston Dry Eye Clinic | Birmingham | West Midlands | B4 7ET | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21450918 | Background | 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. | |
| 23108007 | Background |
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Deidentified datasets will be available upon request.
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Deidentified datasets will be available upon request.
Deidentified datasets will be available upon request.
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This is a paired eye randomised clinical trial, that is one eye of a participant is randomised to being treated with actual IPL and LLLT, while the other eye of the same participant is randomised to being treated with Sham IPL and LLLT. Hence, 26 participants were recruited, with 26 eyes randomised to having the first treatment, while the contralateral 26 eyes were randomised to the second treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 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. Actual IPL: 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 IPL: Simulated five light pulses along lower lid region of the other eye of the same participant LLLT: Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | One eye of the participants were randomly allocated to receving actual IPL and LLLT, while the other eye received sham IPL and LLLT. IPL 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. Actual IPL: 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 IPL: Simulated five light pulses along lower lid region of the other eye of the same participant LLLT: Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | seconds | Baseline and 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
|
Duration of study from baseline to final follow-up (up to 6 month and 2 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Actual IPL and LLLT | 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. Actual IPL: 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 LLLT: Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor James S Wolffsohn | Aston University | 07833049245 | j.s.w.wolffsohn@aston.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2024 | May 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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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.
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| Sham IPL | Device | Simulated five light pulses along lower lid region of the other eye of the same participant |
|
| 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 |
|
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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). | 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). | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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 |
Measure of saturation of oxygen in the blood of the lower eyelid measured using tissue oximetry. |
| 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 | Measure of tissue oximetry for the the percentage of red blood cells in the total volume of blood. | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
| Change From Baseline in Fluorescence Measures of NADH of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of the amount of nicotinamide-adenine dinucleotide within the lower eyelid cutaneous skin, with higher values indicating increased nicotinamide-adenine dinucleotide content. | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
| Change From Baseline in Fluorescence Measures of Flavins of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of the amount of flavins, specifically flavin adenine dinucleotide, within the lower eyelid cutaneous skin. | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
| Change From Baseline in Optical Redox Ratio of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | The fluorescence intensity ratio between NADH and FAD used as a diagnostic parameter. | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) |
| 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. |
| 28736342 | 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. |
| 10815152 | 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. |
| 20093066 | 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. |
| 27345733 | 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. |
| 40494722 | Derived | Chiang 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Systemic comorbidities | Count of Participants | Participants |
|
| Fitzpatrick skin type (I to IV) | This is a skin type grading scale for classifying the skin type of the participant based on the skin pigmentation content and reaction to UV. The higher the grade, the darker the skin and the more likely to tan as well as less likely to burn. | Count of Participants | Participants |
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| Existing dry eye interventions | Count of Participants | Participants |
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| OG001 | Sham IPL and LLLT | 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. Sham IPL: Simulated five light pulses along lower lid region of the other eye of the same participant LLLT: Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
|
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
|
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mm | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | count of total blinks | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | count of lashes with Demodex | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | blocked or capped meibomian glands | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mm/mm^2 | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mm/mm^2 | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | cells/mm^2 | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | count of partial blinks | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | cells/mm^2 | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Blood Perfusion of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of blood flow using laser doppler flowmetry instrument, with higher values indicating better perfusion. | Posted | Mean | 95% Confidence Interval | arbitrary units (AU) | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Microvasculature Blood Oxygen Saturation of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of saturation of oxygen in the blood of the lower eyelid measured using tissue oximetry. | Posted | Mean | 95% Confidence Interval | percentage of saturation | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Relative Erythrocyte Fraction Volume of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of tissue oximetry for the the percentage of red blood cells in the total volume of blood. | Posted | Mean | 95% Confidence Interval | percentage of RBC in blood | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Fluorescence Measures of NADH of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of the amount of nicotinamide-adenine dinucleotide within the lower eyelid cutaneous skin, with higher values indicating increased nicotinamide-adenine dinucleotide content. | Posted | Mean | 95% Confidence Interval | arbitrary units (AU) | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Fluorescence Measures of Flavins of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | Measure of the amount of flavins, specifically flavin adenine dinucleotide, within the lower eyelid cutaneous skin. | Posted | Mean | 95% Confidence Interval | arbitrary units (AU) | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| Other Pre-specified | Change From Baseline in Optical Redox Ratio of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session | The fluorescence intensity ratio between NADH and FAD used as a diagnostic parameter. | Posted | Mean | 95% Confidence Interval | ratio | Baseline up to 3 months after final treatment session (up to 6 months after Baseline) | Eyes | Eyes |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Sham IPL and LLLT | 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. Sham IPL: Simulated five light pulses along lower lid region of the other eye of the same participant LLLT: Mask with LEDs transferring a total of about 32 J/cm^2 of energy to facial and eyelids region with their eyes closed | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided