NCT05487547

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

July 31, 2022

Last Update Submit

January 16, 2023

Conditions

Dry Eye DiseaseMeibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks after the 4th treatment session

Secondary Outcomes (5)

  • OSDI

    4 weeks after the 4th treatment session

  • Eyelid appearance

    4 weeks after the 4th treatment session

  • Number of expressible glands

    4 weeks after the 4th treatment session

  • NIBUT

    4 weeks after the 4th treatment session

  • Meibography

    4 weeks after the 4th treatment session

Other Outcomes (2)

  • Predominant quality of the meibum

    4 weeks after the 4th treatment session

  • MMP-9 test

    4 weeks after the 4th treatment session

Study Arms (1)

Study arm

EXPERIMENTAL

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.

Device: IPL_RF_MGX

Interventions

IPL_RF_MGXDEVICE

intense pulsed light followed by Radiofrequency followed by meibomian gland expression

Study arm

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is able to read, understand and sign an IC form
  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manhattan Face and Eye clinic

New York, New York, 10019, United States

Location

Carolina Eye Doctors

Harrisburg, North Carolina, 28075, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • James Chelnis, MD

    Manhattan Face and Eye

    PRINCIPAL INVESTIGATOR

  • Chantel Garcia, OD

    Carolina Eye Doctors

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 4, 2022

Study Start

July 21, 2022

Primary Completion

December 28, 2022

Study Completion

December 28, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

No plan

Locations

US(2)