Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

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

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

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction; Dry Eye Disease
• Intervention / Treatment: Combination product: Protection of eyes with tinted soft scleral eye shields

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids	Combination product: Protection of eyes with tinted soft scleral eye shields; In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids; Other Names: IPL adminstration on eyelids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ophthalmic morphological changes at 1 week after intervention	Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 1 week after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ophthalmic morphological changes at 10 minutes after intervention	Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 10 minutes after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)	10 minutes
Ophthalmic morphological changes at 24 hours after intervention	Opinion of the study investigator (yes/no) whether there was any change in ocular structures at 24 hours after intervention (based on a series of tests including biomicroscopy, corneal fluorescein staining, anterior segment OCT, posterior segment OCT, and specular microscopy)	24 hours
Objective functional change at 10 minutes after intervention	Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention	10 minutes
Objective functional change at 24 hours after intervention	Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention	24 hours
Objective functional change at 1 week after intervention	Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention	1 week
Subjective functional change at 10 minutes after intervention	Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention	10 minutes
Subjective functional change at 1 day after intervention	Change in perception of visual symptoms (Visual analog scale) at 1 day after intervention	1 day
Subjective functional change at 1 week after intervention	Change in perception of visual symptoms (Visual analog scale) at 1 week after intervention	1 week

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Rolando Toyos, MD, Toyos Clinic (Nashville, TN, USA)

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: LUM-VBU-OPT-21-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No