Clinical trial NCT04730336: Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
Official title: Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo three sessions of treatments with the Investigation devise
Primary purpose: TREATMENT

Brief summary: Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs

Detailed description: Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye

Eligibility criteria: 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 impaired skin healing during the last 3 months.
* Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
* Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
* Any patient who has tattoos or permanent makeup in the treated area.
* Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
* Any patient who underwent thread lifting of the area to be treated in the last 3 months.

Primary outcomes:
measure: NIBUT in Seconds
timeFrame: 18 Weeks
measure: Ocular Surface Disease Index questionnaire
timeFrame: 18 Weeks
measure: SAFETY, number of AEs
timeFrame: 18 Weeks
Secondary outcomes:
measure: Topography mm D
timeFrame: 18 Weeks
measure: Slit Lamp Exam; Normal, Abnormal
timeFrame: 18 Weeks
measure: Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
timeFrame: 18 Weeks
measure: Lid margin profile
timeFrame: 18 Weeks
measure: Tear Sampling Analysis
timeFrame: 18 Weeks
measure: Staining; Total Ocular Staining Score
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Solihull
country: United Kingdom
facility: Midland Eye
Study officials:
affiliation: Midland Eye
name: Sunil Shah, Phd
role: PRINCIPAL_INVESTIGATOR
References: