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

• Sponsor: Lumenis Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05168670
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 17.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease; Meibomian Gland Dysfunction	Combination Product: Protection of eyes with tinted soft scleral eye shields	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 21, 2021
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ophthalmic morphological changes at 1 week after intervention [1 week]

   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)

Secondary Outcome Measures

1. Ophthalmic morphological changes at 10 minutes after intervention [10 minutes]

   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)

2. Ophthalmic morphological changes at 24 hours after intervention [24 hours]

   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)

3. Objective functional change at 10 minutes after intervention [10 minutes]

   Change in best-corrected visual acuity (ETDRS chart) at 10 minutes after intervention

4. Objective functional change at 24 hours after intervention [24 hours]

   Change in best-corrected visual acuity (ETDRS chart) at 24 hours after intervention

5. Objective functional change at 1 week after intervention [1 week]

   Change in best-corrected visual acuity (ETDRS chart) at 1 week after intervention

6. Subjective functional change at 10 minutes after intervention [10 minutes]

   Change in perception of visual symptoms (Visual analog scale) at 10 minutes after intervention

7. Subjective functional change at 1 day after intervention [1 day]

   Change in perception of visual symptoms (Visual analog scale) at 1 day after intervention

8. Subjective functional change at 1 week after intervention [1 week]

   Change in perception of visual symptoms (Visual analog scale) at 1 week after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toyos Clinic	Nashville	Tennessee	United States	37215

Sponsors and Collaborators

• Lumenis Ltd.

Investigators

• Principal Investigator: Rolando Toyos, MD, Toyos Clinic (Nashville, TN, USA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lumenis Ltd.
• ClinicalTrials.gov Identifier: NCT05168670
• Other Study ID Numbers: LUM-VBU-OPT-21-02
• First Posted: Dec 23, 2021
• Last Update Posted: May 26, 2022
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Meibomian Gland Dysfunction

Study Results

No Results Posted as of May 26, 2022