Clinical trial NCT05487547: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Meibomian Gland Dysfunction
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 33
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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hand, several researchers reported that application of RF around the eyelids provide immediate relief of DED symptoms (unpublished observations: Dr.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.

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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

Primary outcomes:
measure: modified meibomian gland score (mMGS)
timeFrame: 4 weeks after the 4th treatment session
Secondary outcomes:
measure: OSDI
timeFrame: 4 weeks after the 4th treatment session
measure: Eyelid appearance
timeFrame: 4 weeks after the 4th treatment session
measure: Number of expressible glands
timeFrame: 4 weeks after the 4th treatment session
measure: NIBUT
timeFrame: 4 weeks after the 4th treatment session
measure: Meibography
timeFrame: 4 weeks after the 4th treatment session
Other outcomes:
measure: Predominant quality of the meibum
timeFrame: 4 weeks after the 4th treatment session
measure: MMP-9 test
timeFrame: 4 weeks after the 4th treatment session
Locations:
city: New York
country: United States
facility: Manhattan Face and Eye clinic
state: New York
city: Harrisburg
country: United States
facility: Carolina Eye Doctors
state: North Carolina
Study officials:
affiliation: Manhattan Face and Eye
name: James Chelnis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Eye Doctors
name: Chantel Garcia, OD
role: PRINCIPAL_INVESTIGATOR
References: