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Feasibility of IPL Combined With RF for Treatment of DED Due to MGD

Primary Purpose

Dry Eye Disease, Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPL_RF_MGX
Sponsored by
Lumenis Be Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 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 IC form
  • 22 or older
  • Self-assessed symptoms are consistent with moderate to severe dry eye (OSDI score ≥ 23)
  • Signs of MGD, as detected in biomicroscopy
  • Modified Meibomian Gland Score (mMGS) > 12 in the lower eyelid of at least one eye
  • Fitzpatrick skin type I-IV
  • Subject is willing to comply with all study procedures

Exclusion Criteria:

  • Fitzpatrick skin type V or VI
  • Pacemaker
  • Any metal implants above the neck, excluding dental implants
  • Dry Eye due to Sjogren
  • LASIK/SMILE surgery, within 1 year prior to screening
  • RK surgery
  • Other ocular surgery or eyelid surgery, within 3 months prior to screening
  • Recent ocular trauma, within 3 months prior to screening
  • Pre-cancerous lesions or skin cancer in the planned treatment area
  • Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
  • Uncontrolled infections or uncontrolled immunosuppressive diseases
  • Legally blind in either eye worse than 20/200
  • Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy (EBMD)
  • Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, Grading staining in the lower third secondary to lagophthalmos, severe trichiasis, and severe ptosis
  • 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
  • Active sun burn in the treatment area
  • Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
  • Anterior chamber inflammation
  • Corneal edema
  • 4 weeks wash out of all prescription eye drops, excluding artificial lubricants
  • No more than 75% loss of meibomian glands, as evaluated with meibography, in either lower eyelid
  • Any non-prescription product for dry eye, within 1 month from the study, excluding artificial lubricants
  • Any condition revealed whereby the investigator deems the subject inappropriate for this study

Sites / Locations

  • Manhattan Face and Eye clinic
  • Carolina Eye Doctors

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Subjects will receive 4 treatments at 2-weeks intervals. Each treatment will consist of IPL administered on the malar region, followed by RF administered around the eye, followed by Meibomian gland expression (MGX). Follow-up will be conducted at 4 weeks after the 4th treatment session.

Outcomes

Primary Outcome Measures

modified meibomian gland score (mMGS)
15 meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). mMGS will be evaluated as the sum of scores for these 15 glands.

Secondary Outcome Measures

OSDI
Ocular Surface Disease Index questionnaire
Eyelid appearance
Eyelid appearance will be assessed with biomicroscopy at the slit lamp. Five features of the eyelids will be scored: lid margin vascularity, eyelid thickness, loss of eyelashes, conjunctival injection, and plugging of meibomian gland orifices. Each feature will be scored using a 4 point grading system: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Number of expressible glands
Glands along the upper and lower lids will be squeezed with a dedicated expression forceps. The number of glands expressing any meibum (clear liquid, cloudy liquid, or inspissated) will be counted, per each eyelid separately.
NIBUT
The non-invasive breakup time (NIBUT) will be measured with the tear film analysis feature of the Antares system (CSO). The subject will be asked to maintain his/her eye open, without blinking, in front of a device that will project concentric Placido disks will be projected onto the ocular surface. Mire reflections of these placido disks will be monitored. The first occurrence of image distortion will
Meibography
The study investigator will invert the eyelids of the subject, to expose the meibomian glands. After viewing the inverted eyelids with infra-red light illumination using the Antares system (CSO), an infra-red image of the meibomian glands will be captured cand saved. The Antares software will be use to calculate the area of meibomian gland loss

Full Information

First Posted
July 31, 2022
Last Updated
January 16, 2023
Sponsor
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05487547
Brief Title
Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
Official Title
Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this single-arm pilot study is to evaluate the feasibility and safety of combination therapy of intense pulsed light (IPL) and (Radiofrequency) RF for treatment of Dry eye disease (DED) due to Meibomian gland dysfunction (MGD).
Detailed Description
In the past several years, a large number of studies have demonstrated that several sessions of IPL followed by MGX lead to a long-term reduction in signs and symptoms of DED due to MGD, however benefits for the patient are expected only after 2 or 3 sessions. On the other hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr. Chantel Garcia). The efficacy of RF for reduction of DED signs and symptoms was also demonstrated in two clinical studies and one animal model of obstructive MGD. Despite the small number of studies with RF, these preliminary results suggest that the combination of IPL, MGX and RF could provide immediate symptomatic relief together with long-term improvement of signs and symptoms of DED. In addition, combination therapy might be useful to increase the efficacy of monotherapy RF or monotherapy IPL. The purpose of this single-arm pilot study is to evaluate the feasibility and safety of combination therapy of IPL and RF for treatment of DED due to MGD. As far as we know this is the first study of its kind. Results of this current study will be useful to choose the most effective outcome measures, to estimate the risk to benefit ratio, and to anticipate the effect size. In the future, such information will be essential for evaluating the merits of this approach, by designing a powered and randomized controlled study. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
Subjects will receive 4 treatments at 2-weeks intervals. Each treatment will consist of IPL administered on the malar region, followed by RF administered around the eye, followed by Meibomian gland expression (MGX). Follow-up will be conducted at 4 weeks after the 4th treatment session.
Intervention Type
Device
Intervention Name(s)
IPL_RF_MGX
Intervention Description
intense pulsed light followed by Radiofrequency followed by meibomian gland expression
Primary Outcome Measure Information:
Title
modified meibomian gland score (mMGS)
Description
15 meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2 = inspissated meibum; 3 = blocked). mMGS will be evaluated as the sum of scores for these 15 glands.
Time Frame
4 weeks after the 4th treatment session
Secondary Outcome Measure Information:
Title
OSDI
Description
Ocular Surface Disease Index questionnaire
Time Frame
4 weeks after the 4th treatment session
Title
Eyelid appearance
Description
Eyelid appearance will be assessed with biomicroscopy at the slit lamp. Five features of the eyelids will be scored: lid margin vascularity, eyelid thickness, loss of eyelashes, conjunctival injection, and plugging of meibomian gland orifices. Each feature will be scored using a 4 point grading system: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Time Frame
4 weeks after the 4th treatment session
Title
Number of expressible glands
Description
Glands along the upper and lower lids will be squeezed with a dedicated expression forceps. The number of glands expressing any meibum (clear liquid, cloudy liquid, or inspissated) will be counted, per each eyelid separately.
Time Frame
4 weeks after the 4th treatment session
Title
NIBUT
Description
The non-invasive breakup time (NIBUT) will be measured with the tear film analysis feature of the Antares system (CSO). The subject will be asked to maintain his/her eye open, without blinking, in front of a device that will project concentric Placido disks will be projected onto the ocular surface. Mire reflections of these placido disks will be monitored. The first occurrence of image distortion will
Time Frame
4 weeks after the 4th treatment session
Title
Meibography
Description
The study investigator will invert the eyelids of the subject, to expose the meibomian glands. After viewing the inverted eyelids with infra-red light illumination using the Antares system (CSO), an infra-red image of the meibomian glands will be captured cand saved. The Antares software will be use to calculate the area of meibomian gland loss
Time Frame
4 weeks after the 4th treatment session
Other Pre-specified Outcome Measures:
Title
Predominant quality of the meibum
Description
The predominant quality of the meibum represents the quality of the meibum expressed from the majority of the meibomian glands. This will be assessed using a 4 point grading system: 0 = clear liquid, 1 = cloud liquid, 2 = inspissated, and 3 = no expression
Time Frame
4 weeks after the 4th treatment session
Title
MMP-9 test
Description
Presence/Absence of MMP-9 in tear samples will be evaluated with the InflammaDry test (Pathogen Screening, Sarasota, FL).
Time Frame
4 weeks after the 4th treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is able to read, understand and sign an IC form 22 or older Self-assessed symptoms are consistent with moderate to severe dry eye (OSDI score ≥ 23) Signs of MGD, as detected in biomicroscopy Modified Meibomian Gland Score (mMGS) > 12 in the lower eyelid of at least one eye Fitzpatrick skin type I-IV Subject is willing to comply with all study procedures Exclusion Criteria: Fitzpatrick skin type V or VI Pacemaker Any metal implants above the neck, excluding dental implants Dry Eye due to Sjogren LASIK/SMILE surgery, within 1 year prior to screening RK surgery Other ocular surgery or eyelid surgery, within 3 months prior to screening Recent ocular trauma, within 3 months prior to screening Pre-cancerous lesions or skin cancer in the planned treatment area Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface Uncontrolled infections or uncontrolled immunosuppressive diseases Legally blind in either eye worse than 20/200 Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy (EBMD) Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, Grading staining in the lower third secondary to lagophthalmos, severe trichiasis, and severe ptosis 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 Active sun burn in the treatment area Moderate to severely compromised corneal health as assessed by corneal fluorescein staining Anterior chamber inflammation Corneal edema 4 weeks wash out of all prescription eye drops, excluding artificial lubricants No more than 75% loss of meibomian glands, as evaluated with meibography, in either lower eyelid Any non-prescription product for dry eye, within 1 month from the study, excluding artificial lubricants Any condition revealed whereby the investigator deems the subject inappropriate for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Chelnis, MD
Organizational Affiliation
Manhattan Face and Eye
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chantel Garcia, OD
Organizational Affiliation
Carolina Eye Doctors
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Face and Eye clinic
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Carolina Eye Doctors
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan

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Feasibility of IPL Combined With RF for Treatment of DED Due to MGD

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