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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05168670
• Other study ID #: LUM-VBU-OPT-21-02
• Status: Completed
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: November 2021
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Toyos Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Objective functional change at 10 minutes after intervention	Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention	10 minutes
Secondary	Objective functional change at 24 hours after intervention	Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention	24 hours
Secondary	Objective functional change at 1 week after intervention	Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention	1 week
Secondary	Subjective functional change at 10 minutes after intervention	Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention	10 minutes
Secondary	Subjective functional change at 1 day after intervention	Change in perception of visual symptoms (Visual analog scale) at 1 day; after intervention	1 day
Secondary	Subjective functional change at 1 week after intervention	Change in perception of visual symptoms (Visual analog scale) at 1 week; after intervention	1 week