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
Verified date | November 2021 |
Source | Lumenis Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Toyos Clinic | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Lumenis Ltd. |
United States,
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 |
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