Trial Outcomes & Findings for Mechanisms of Light-based Therapies for Dry Eye Disease (NCT NCT06004895)
NCT ID: NCT06004895
Last Updated: 2025-07-23
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline and 3 months after final treatment session (up to 6 months after Baseline)
Results posted on
2025-07-23
Participant Flow
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.
Unit of analysis: Eyes of participants
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
26 52
|
|
Overall Study
COMPLETED
|
24 48
|
|
Overall Study
NOT COMPLETED
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2 4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Development of a stye in the upper left eyelid detected at the second visit
|
1
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Overall Study
Prescribed with corticosteroid eyedrops by their eye care clinician following the baseline visit
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1
|
Baseline Characteristics
Mechanisms of Light-based Therapies for Dry Eye Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 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
|
|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Sex: Female, Male
Female
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19 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
2 Participants
n=5 Participants
|
|
Systemic comorbidities
Hypertension
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3 Participants
n=5 Participants
|
|
Systemic comorbidities
Hypercholesterolaemia
|
2 Participants
n=5 Participants
|
|
Systemic comorbidities
Hypothyroidism
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2 Participants
n=5 Participants
|
|
Systemic comorbidities
Asthma
|
1 Participants
n=5 Participants
|
|
Systemic comorbidities
Vitamin B12 deficiency
|
1 Participants
n=5 Participants
|
|
Systemic comorbidities
Arthritis
|
1 Participants
n=5 Participants
|
|
Systemic comorbidities
Raynaud's phenonemon
|
1 Participants
n=5 Participants
|
|
Fitzpatrick skin type (I to IV)
I
|
1 Participants
n=5 Participants
|
|
Fitzpatrick skin type (I to IV)
II
|
14 Participants
n=5 Participants
|
|
Fitzpatrick skin type (I to IV)
III
|
5 Participants
n=5 Participants
|
|
Fitzpatrick skin type (I to IV)
IV
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4 Participants
n=5 Participants
|
|
Existing dry eye interventions
Lubricating eyedrops, gel or ointment
|
19 Participants
n=5 Participants
|
|
Existing dry eye interventions
Warm compresses
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3 Participants
n=5 Participants
|
|
Existing dry eye interventions
Eyelid cleansers
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2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
|
-2.61 seconds
Interval -5.91 to 0.69
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-0.85 seconds
Interval -3.31 to 1.62
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SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index Scores to the Final Follow-up 3 Months After Final Treatment Session
|
-11.34 score on a scale
Interval -21.78 to -0.9
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-11.34 score on a scale
Interval -21.78 to -0.9
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SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in 5-Item Dry Eye Questionnaire Scores to the Final Follow-up 3 Months After Final Treatment Session
|
-3.29 score on a scale
Interval -5.95 to -0.63
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-3.29 score on a scale
Interval -5.95 to -0.63
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Tear Meniscus Height to the Final Follow-up 3 Months After Final Treatment Session
|
0.03 mm
Interval -0.77 to 0.07
|
0.05 mm
Interval -0.008 to 0.1
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SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Lipid Layer Pattern Grading to the Final Follow-up 3 Months After Final Treatment Session
|
0.54 units on a scale
Interval -0.08 to 1.16
|
0.38 units on a scale
Interval -0.27 to 1.02
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SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 3 Months After Final Treatment Session
|
0.05 units on a scale
Interval -0.33 to 0.33
|
-0.12 units on a scale
Interval -0.37 to 0.13
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Manual subjective count of the number of total blinks using the Oculus Keratograph 5M instrument.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Total Blinks to the Final Follow-up 3 Months After Final Treatment Session
|
-0.96 count of total blinks
Interval -2.55 to 4.47
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-0.96 count of total blinks
Interval -2.55 to 4.47
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session
|
-0.02 units on a scale
Interval -0.07 to 0.04
|
0.002 units on a scale
Interval -0.04 to 0.05
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session
|
-0.46 units on a scale
Interval -1.08 to 0.16
|
-0.29 units on a scale
Interval -0.93 to 0.35
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session
|
-0.42 units on a scale
Interval -0.9 to 0.06
|
-0.29 units on a scale
Interval -0.66 to 0.08
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session
|
0.31 units on a scale
Interval -0.1 to 0.73
|
0.15 units on a scale
Interval -0.45 to 0.74
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Lower Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
|
-0.08 units on a scale
Interval -0.3 to 0.13
|
0.08 units on a scale
Interval -0.13 to 0.3
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session
|
-0.04 count of lashes with Demodex
Interval -0.28 to 0.2
|
-0.17 count of lashes with Demodex
Interval -0.49 to 0.16
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Subjective assessment of the number of blocked or capped Meibomian Glands using slit lamp biomicroscopy and white light illumination.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session
|
0 blocked or capped meibomian glands
Interval 0.0 to 0.0
|
0 blocked or capped meibomian glands
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session
|
-0.33 units on a scale
Interval -0.8 to 0.14
|
-0.29 units on a scale
Interval -0.75 to 0.17
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session
|
-0.35 units on a scale
Interval -0.8 to 0.11
|
-0.50 units on a scale
Interval -0.82 to -0.18
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session
|
-0.07 units on a scale
Interval -0.55 to 0.4
|
0.08 units on a scale
Interval -0.4 to 0.55
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Total Central Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
|
-0.76 mm/mm^2
Interval -2.26 to 0.73
|
0.18 mm/mm^2
Interval -1.42 to 1.78
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Total Inferior Whorl Nerve Length to the Final Follow-up 3 Months After Final Treatment Session
|
-2.15 mm/mm^2
Interval -5.27 to 0.98
|
-0.15 mm/mm^2
Interval -2.16 to 1.86
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of memory T-cell density from sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Putative Tissue-Resident Memory T-Cell Density to the Final Follow-up 3 Months After Final Treatment Session
|
-0.65 cells/mm^2
Interval -7.67 to 6.37
|
-4.95 cells/mm^2
Interval -26.67 to 16.78
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Frequency Scores to the Final Follow-up 3 Months After Final Treatment Session
|
-21.63 score on a scale
Interval -38.48 to -4.77
|
-20.54 score on a scale
Interval -37.91 to -3.17
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Severity Scores to the Final Follow-up 3 Months After Final Treatment Session
|
-18.54 score on a scale
Interval -34.45 to -2.63
|
-16.75 score on a scale
Interval -34.37 to 0.87
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Manual subjective count of the number of partial blinks using the Oculus Keratograph 5M instrument.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Partial Blinks to the Final Follow-up 3 Months After Final Treatment Session
|
-2.04 count of partial blinks
Interval -5.65 to 1.56
|
-2.04 count of partial blinks
Interval -5.65 to 1.56
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)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).
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Upper Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of dendritic cell density from sub-basal nerve plexi images obtained from in-vivo corneal confocal microscopy.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Putative Dendritic Cell Density to the Final Follow-up 3 Months After Final Treatment Session
|
1.24 cells/mm^2
Interval -1.78 to 4.25
|
0.98 cells/mm^2
Interval -1.64 to 3.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of blood flow using laser doppler flowmetry instrument, with higher values indicating better perfusion.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Blood Perfusion of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
-1.03 arbitrary units (AU)
Interval -5.97 to 3.91
|
-1.65 arbitrary units (AU)
Interval -6.19 to 2.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of saturation of oxygen in the blood of the lower eyelid measured using tissue oximetry.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Microvasculature Blood Oxygen Saturation of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
0.98 percentage of saturation
Interval -6.92 to 8.87
|
4.33 percentage of saturation
Interval -6.92 to 15.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of tissue oximetry for the the percentage of red blood cells in the total volume of blood.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 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
LLLT: Mask with LEDs transferring a total of about 32 J/cm\^2 of energy to facial and eyelids region with their eyes closed
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Relative Erythrocyte Fraction Volume of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
0.22 percentage of RBC in blood
Interval -2.12 to 2.56
|
1.29 percentage of RBC in blood
Interval -1.07 to 3.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of the amount of nicotinamide-adenine dinucleotide within the lower eyelid cutaneous skin, with higher values indicating increased nicotinamide-adenine dinucleotide content.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Fluorescence Measures of NADH of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
-0.47 arbitrary units (AU)
Interval -51.96 to 51.01
|
-9.12 arbitrary units (AU)
Interval -51.69 to 33.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)Measure of the amount of flavins, specifically flavin adenine dinucleotide, within the lower eyelid cutaneous skin.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Fluorescence Measures of Flavins of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
-18.64 arbitrary units (AU)
Interval -39.48 to 2.2
|
-7.64 arbitrary units (AU)
Interval -26.1 to 10.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 3 months after final treatment session (up to 6 months after Baseline)The fluorescence intensity ratio between NADH and FAD used as a diagnostic parameter.
Outcome measures
| Measure |
Actual IPL and LLLT
n=24 Eyes
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
|
Sham IPL and LLLT
n=24 Eyes
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
|
|---|---|---|
|
Change From Baseline in Optical Redox Ratio of Lower Eyelid to the Final Follow-up 3 Months After Final Treatment Session
|
0.28 ratio
Interval -0.31 to 0.86
|
-0.16 ratio
Interval -0.81 to 0.5
|
Adverse Events
Actual IPL and LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham IPL and LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place