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Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IPL

Sham IPL

MGX

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is able to read, understand and sign an Informed Consent (IC) form
22-85 years of age
Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds
In the study eye, Meibomian Gland Score (MGS) ≤ 12
In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23

Exclusion Criteria:

Fitzpatrick skin type V or VI
Contact lens wear within the month prior to screening
Unwilling to discontinue use of contact lenses for the duration of the study
Ocular surgery or eyelid surgery, within 6 months prior to screening
Neuro-paralysis in the planned treatment area, within 6 months prior to screening
Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
Current use of punctal plugs
Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
Uncontrolled infections or uncontrolled immunosuppressive diseases
Subjects with ocular infections, within 6 months prior to screening
Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria
Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
Over exposure to sun, within 4 weeks prior to screening
Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
Radiation therapy to the head or neck, within 12 months prior to screening
Planned radiation therapy, within 8 weeks after the last treatment session
Treatment with chemotherapeutic agent, within 8 weeks prior to screening
Planned chemotherapy, within 8 weeks after the last treatment session
New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears
Change in dosage of any systemic medication, within 3 months prior to screening
Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
Legally blind in either eye
History of migraines, seizures or epilepsy
Facial IPL treatment, within 12 months prior to screening
Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening
Expression of the meibomian glands, within 6 months prior to screening
In either eye, moderate to severe (Grade 3-4) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
In either eye, severe (Grade 4) inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis
Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome
Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit.
Any condition revealed whereby the investigator deems the subject inappropriate for this study

Sites / Locations

Toyos Clinic
Dell Laser Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

IPL followed by Meibomian Gland Expression (MGX)

Sham IPL followed by MGX

Arm Description

Subjects in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes.

Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes.

Outcomes

Primary Outcome Measures

Change of Baseline Tear Breakup Time (TBUT)

Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

Secondary Outcome Measures

Change From Baseline Ocular Surface Disease Index (OSDI)

Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up. OSDI was collected per patient (one number per patient). The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye.

Change From Baseline Eye Dryness Score (EDS)

Change of self-assessed symptoms on a visual analog scale (VAS) , from baseline to follow-up, in both eyes. Values were collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. VAS scores are not validated for dry eye. Hence, it is not known how to correlate VAS values to severity levels of dry eye. However, one can make estimations from the literature of VAS in other conditions. For example, in patients with chronic musculoskeletal pain, in a VAS scale of 0 to 10 scores below 3.4 corresponded to mild pain, scores between 3.5 and 7.4 corresponded to moderate pain, and scores above 7.5 corresponded to severe pain. Using such results from other conditions, it is *estimated* that values between 0 and 34 correspond to mild symptoms, scores between 35 and 74 correspond to moderate symptoms, and scores above 75 correspond to severe symptoms.

Full Information

NCT ID

NCT03396913

First Posted

December 28, 2017

Last Updated

November 15, 2020

Sponsor

Lumenis Be Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03396913

Brief Title

Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Official Title

Effectiveness of Intense Pulsed Light for Improving Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

August 15, 2019 (Actual)

Study Completion Date

August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lumenis Be Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.

Detailed Description

Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with intense pulsed light (IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms. For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline). Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.

Masking

Participant

Masking Description

Subjects in the study arm will receive a series of IPL pulses using the M22 IPL handpiece. In subjects of the control arm, the device will be disabled. The subject will feel the lightguide on the skin, will hear clicking sounds, but no light will be actually produced by the M22 device. Since during treatment both eyes of the subject will be fully occluded, no subject will be able to see if the treatment is actual or sham. There is no way to completely mask the subjects, since the IPL generally causes slight redness of the skin, and in some patients is may also cause some discomfort

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPL followed by Meibomian Gland Expression (MGX)

Arm Type

Experimental

Arm Description

Arm Title

Sham IPL followed by MGX

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

IPL

Intervention Description

Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

Intervention Type

Device

Intervention Name(s)

Sham IPL

Intervention Description

Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

Intervention Type

Procedure

Intervention Name(s)

MGX

Intervention Description

Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps

Primary Outcome Measure Information:

Title

Change of Baseline Tear Breakup Time (TBUT)

Description

Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline Ocular Surface Disease Index (OSDI)

Description

Time Frame

10 weeks

Title

Change From Baseline Eye Dryness Score (EDS)

Description

Time Frame

10 weeks

Other Pre-specified Outcome Measures:

Title

Qualitative Assessment of Eyelid Appearance

Description

High resolution photos of the upper and lower eyelids in both eyes

Time Frame

10 weeks

Title

Meiboscore

Description

The difference in the percentage of area loss of meibomian glands, as evaluated using meibography, between eyes in the study arm and eyes in the control arm

Time Frame

10 weeks

Title

Percentage of Eyes With Normal Tear Break-Up Time (TBUT)

Description

The difference in the proportion of eyes with normal TBUT (TBUT > 10 sec) at follow-up, between study eyes in the study arm and study eyes in the control arm

Time Frame

10 weeks

Title

Percentage of Subjects With Normal Ocular Surface Disease Index (OSDI)

Description

The difference in the proportion of subjects with normal OSDI (OSDI < 23) at FU, between study eyes in the study arm and study eyes in the control arm

Time Frame

10 weeks

Title

Incidence of Ocular Adverse Events

Description

The difference in the incidence of ocular adverse events, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

Title

Incidence of Non-ocular Adverse Events

Description

The difference in the incidence of non ocular adverse events, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

Title

Incidence of Unanticipated Serious Adverse Events

Description

The difference in the incidence of unanticipated serious adverse events, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

Title

Immediate Biomicroscopy

Description

difference in the change of bio-microscopy examinations pre- and post- treatment, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

Title

Pain/Discomfort During Intense Pulsed Light (IPL)

Description

The difference in the self-assessment of pain/discomfort during IPL administration, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

Title

Pain/Discomfort During Meibomian Gland Expression (MGX)

Description

The difference in the self-assessment of pain/discomfort during MGX, between subjects in the study arm and subjects in the control arm

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able to read, understand and sign an Informed Consent (IC) form 22-85 years of age Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements In the study eye, Tear Breakup time (TBUT) ≤ 7 seconds In the study eye, Meibomian Gland Score (MGS) ≤ 12 In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23 Exclusion Criteria: Fitzpatrick skin type V or VI Contact lens wear within the month prior to screening Unwilling to discontinue use of contact lenses for the duration of the study Ocular surgery or eyelid surgery, within 6 months prior to screening Neuro-paralysis in the planned treatment area, within 6 months prior to screening Other uncontrolled eye disorders affecting the ocular surface, for example active allergies Current use of punctal plugs Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area Uncontrolled infections or uncontrolled immunosuppressive diseases Subjects with ocular infections, within 6 months prior to screening Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort Over exposure to sun, within 4 weeks prior to screening Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops Radiation therapy to the head or neck, within 12 months prior to screening Planned radiation therapy, within 8 weeks after the last treatment session Treatment with chemotherapeutic agent, within 8 weeks prior to screening Planned chemotherapy, within 8 weeks after the last treatment session New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears Change in dosage of any systemic medication, within 3 months prior to screening Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period Legally blind in either eye History of migraines, seizures or epilepsy Facial IPL treatment, within 12 months prior to screening Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening Expression of the meibomian glands, within 6 months prior to screening In either eye, moderate to severe (Grade 3-4) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis In either eye, severe (Grade 4) inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy) Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit. Any condition revealed whereby the investigator deems the subject inappropriate for this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven J Dell, MD

Organizational Affiliation

Dell Laser Consultants

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rolando Toyos, MD

Organizational Affiliation

Toyos Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neel Desai, MD

Organizational Affiliation

The Eye Institute of West Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Dell Laser Consultants

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

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