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

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