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

NCT05168670 | Completed

• 1 other identifier: LUM-VBU-OPT-21-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ophthalmic morphological changes at 10 minutes after intervention

  10 minutes

• Ophthalmic morphological changes at 24 hours after intervention

  24 hours

• Objective functional change at 10 minutes after intervention

  10 minutes

• Objective functional change at 24 hours after intervention

  24 hours

• Objective functional change at 1 week after intervention

  1 week

Study Arms (1)

Study arm

EXPERIMENTAL

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

Interventions

Protection of eyes with tinted soft scleral eye shields COMBINATION_PRODUCT

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

Also known as: IPL adminstration on eyelids

Study arm

Eligibility Criteria

• Age: 22 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to read, understand and sign an IC form
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Rolando Toyos, MD

  Toyos Clinic (Nashville, TN, USA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 23, 2021
• Study Start: December 21, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: May 26, 2022

Record last verified: 2021-11

Locations

US (1)