Phase
Condition
Sjogren's Syndrome
Dry Eyes
Dry Eye Disease
Treatment
Intense pulsed light with C.STIM device
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is able to read, understand and sign an information consent and image rightforms
aged over 22 years old
Fitzpatrick skin type I-IV
Patient is able and willing to comply with the treatment/FU schedule andrequirements
Meibomian Gland Score : Meibum Quality according to Tear Film and Occular SurfaceSociety recommendation: ≥ 16 for 1 eye and 8 central glands in the lower eyelid
At least 5 non-atrophied meibomian glands in the lower eyelid
Tear break-up time (TBUT) ≤ 10 seconds
Symptoms self-assessed using the Occular Surface Disease Index questionnaire ≥ 23
Exclusion
Exclusion Criteria:
Fitzpatrick skin type V or VI
Contact lens wear within the month prior to screening
Unwilling to discontinue use of contact lenses for the duration of the study
Ocular surgery or eyelid surgery within 6 months prior to screening
Neuro-paralysis in the planned treatment area within 6 months prior to screening
Other uncontrolled eye disorders affecting the ocular surface, for example activeallergies
Current use of punctal plugs
Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatmentarea Uncontrolled infections or uncontrolled immunosuppressive diseases
Patients with ocular infections, within 6 months prior to screening
Prior history of cold sores or rashes in the perioral area or in the plannedtreatment area that could be stimulated by light at a wavelength of 610 nm to 1200nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria
Within 3 months prior to screening, use of photosensitive medication and/or herbsthat may cause sensitivity to 610-1200 nm light exposure, including: Isotretinoin,Tetracycline, Doxycycline, and St. John's Wort
Over exposure to sun, within 4 weeks prior to screening
Using of topical drops, only artificial tears and glaucoma treatments are authorized
Radiation therapy to the head or neck, within 12 months prior to screening
Planned radiation therapy, within 8 weeks after the last treatment session
Treatment with chemotherapeutic agent, within 8 weeks prior to screening
Planned chemotherapy, within 8 weeks after the last treatment session
New topical treatments within the area to be treated (face), or oral therapies,within 3 months prior to screening, analgesics for pain management, oral omega 3fatty acid supplements are authorized
Change in dosage of any systemic medication, within 3 months prior to screening
Anticipated relocation or extensive travel outside of the local study areapreventing compliance with follow-up over the study period
Legally blind in either eye
History of migraines, seizures or epilepsy
Facial Itense Pulsed Light treatment, within 12 months prior to screening
Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior toscreening
Expression of the meibomian glands, within 6 months prior to screening
In either eye, moderate to severe (Grade 3-4 on the EFRON scale) inflammation of theconjunctiva, including: allergic, vernal or giant papillary conjunctivitis
In either eye, severe (Grade 4 on the EFRON scale) inflammation of the eyelid,including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis
Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect,Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy andpterigyum)
Eyelid abnormalities that affect lid function in either eye, including: entropion,ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severeptosis
Any systemic condition that may cause dry eye disease, including: Stevens-Johnsonsyndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis,sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, andSjögren's syndrome
Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Patients mustdiscontinue these medications for at least 1 month prior to the baseline visit.
Any condition revealed whereby the investigator deems the Patient inappropriate forthis study
Study Design
Connect with a study center
Visionary Consultants Inc.
Lexington, Kentucky 40517
United StatesSite Not Available
Triangle Eye Consultants
Raleigh, North Carolina 27617
United StatesSite Not Available
Toyos Clinic
Nashville, Tennessee 37215
United StatesSite Not Available
Eye Centers of Racine & Kenosha
Kenosha, Wisconsin 53142
United StatesSite Not Available
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