Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs (NCT04730336) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
United Kingdom75 participantsStarted 2019-08-09
Plain-language summary
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Mild to Moderate Periorbital wrinkles
* OSDI score of at least 23
* Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
* No other eye or skin or immune problems
* Willing and able to provide written informed consent.
* Willing to participate in all study activities and instructions.
Exclusion Criteria:
* Pregnancy and/or breastfeeding
* Lesions in the periorbital area
* Acute severe blepharitis
* Acute conjunctivitis
* Other concomitant anterior eye disease
* Has undergone outdoors/sunbed tanning during the last 4 weeks
* Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
* Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
* Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
* An impaired immune system condition or use of immunosuppressive medication.
* Collagen disorders, keloid formation and/or abnormal wound healing.
* Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
* Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or …