Clinical trial NCT05168670: Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids
Official title: Safety of Tinted Soft Scleral Eye Shields When IPL is Applied Directly on Eyelids of Subjects With Dry Eye Disease Due to Meibomian Gland Dysfunction
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: 2021-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.

Detailed description: Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Subject is able to read, understand and sign an IC form
* 22 or older
* Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10)
* Signs of MGD, as detected in biomicroscopy
* Fitzpatrick skin type I-V
* Subject is willing to comply with all study procedures, including return to the clinic 1 day and 1 week after the first and only treatment within the scope of the study

Exclusion Criteria:

* • Fitzpatrick skin type VI

  * Ocular surgery or eyelid surgery, within 3 months prior to screening
  * Recent ocular trauma, within 3 months prior to screening
  * Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
  * Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
  * Uncontrolled infections or uncontrolled immunosuppressive diseases
  * Subjects with ocular infections requiring the use of antibiotic treatment, within 3 months prior to screening
  * Legally blind in either eye
  * Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., keratoconus, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, prior chemical burn)
  * Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
  * 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
  * Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
  * Trans-illumination defects
  * Anisocoria or pupil deformation
  * Anterior chamber inflammation
  * Media opacities (cataract, posterior capsule opacification, corneal edema, etc.) that preclude clear visualization of the anterior segment and retina
  * Any condition revealed whereby the investigator deems the subject inappropriate for this study

Primary outcomes:
measure: Ophthalmic morphological changes at 1 week after intervention
timeFrame: 1 week
Secondary outcomes:
measure: Ophthalmic morphological changes at 10 minutes after intervention
timeFrame: 10 minutes
measure: Ophthalmic morphological changes at 24 hours after intervention
timeFrame: 24 hours
measure: Objective functional change at 10 minutes after intervention
timeFrame: 10 minutes
measure: Objective functional change at 24 hours after intervention
timeFrame: 24 hours
measure: Objective functional change at 1 week after intervention
timeFrame: 1 week
measure: Subjective functional change at 10 minutes after intervention
timeFrame: 10 minutes
measure: Subjective functional change at 1 day after intervention
timeFrame: 1 day
measure: Subjective functional change at 1 week after intervention
timeFrame: 1 week
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
Study officials:
affiliation: Toyos Clinic (Nashville, TN, USA)
name: Rolando Toyos, MD
role: PRINCIPAL_INVESTIGATOR
References: