Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs

Dry Eye Clinical Trial

Official title:

Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730336
• Other study ID #: UREC 1524
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2023
• Source: Aston University
• Contact: Sunil Shah, Phd
• Phone: +44 121 711 2020
• Email: s.shah26[@]aston.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Tixel
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

Locations

Country	Name	City	State
United Kingdom	Midland Eye	Solihull

Sponsors (1)

Lead Sponsor	Collaborator
Aston University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIBUT in Seconds	Non-Invasive Break Up Time	18 Weeks
Primary	Ocular Surface Disease Index questionnaire	Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.	18 Weeks
Primary	SAFETY, number of AEs	Any safety related event during the study will be recorded and analyzed	18 Weeks
Secondary	Topography mm D	Topography with K readings	18 Weeks
Secondary	Slit Lamp Exam; Normal, Abnormal	Multiple Slit Lamp tests	18 Weeks
Secondary	Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire	Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms.	18 Weeks
Secondary	Lid margin profile	Lid margin profile	18 Weeks
Secondary	Tear Sampling Analysis	ocular tear biomarkers	18 Weeks
Secondary	Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green	18 Weeks