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Dry Eye DiseaseNCT05487547

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

A study testing IPL_RF_MGX in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Dry Eye Disease, Meibomian Gland Dysfunction
What is being tested?
IPL_RF_MGX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
21 Jul 2022to 28 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Carolina Eye Doctors

    Harrisburg, North Carolina, 28075

  • Manhattan Face and Eye clinic

    New York, New York, 10019

Other trials in United States

About this study

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).

Read the 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.

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Being tested
IPL_RF_MGX
Medical subject headings
Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPL_RF_MGXDevice

    intense pulsed light followed by Radiofrequency followed by meibomian gland expression

Study groups in NCT05487547
Study groupRoleWhat they receive
Study armExperimentalSubjects 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.
Receives: Device: IPL_RF_MGX

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks after the 4th treatment session

Secondary outcomes (5)

  1. OSDI

    Ocular Surface Disease Index questionnaire

    Measured: 4 weeks after the 4th treatment session

  2. 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.

    Measured: 4 weeks after the 4th treatment session

  3. 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.

    Measured: 4 weeks after the 4th treatment session

  4. 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

    Measured: 4 weeks after the 4th treatment session

  5. 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

    Measured: 4 weeks after the 4th treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start21 Jul 2022
  3. Primary completion28 Dec 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487547
Sponsor's protocol ID
LUM-VBU-NUERA-OPT-22-01
Status last verified
Jan 2023
First submitted
31 Jul 2022
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plan

Questions about this trial

What is this clinical trial studying?

A study testing IPL_RF_MGX in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified meibomian gland score (mMGS) (time frame: 4 weeks after the 4th treatment session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05487547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.

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