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

NCT ID: NCT04730336

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2023-10-31

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

Conditions

Dry Eye; Dry Eye Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tixel Treatment

Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions

Group Type: EXPERIMENTAL

Tixel

Intervention Type: DEVICE

Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

Interventions

Tixel

Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

Intervention Type: DEVICE

Other Intervention Names

Fractional

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Shah, Phd

Role: PRINCIPAL_INVESTIGATOR

Midland Eye

Locations

Midland Eye

Solihull, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sunil Shah, Phd

Role: CONTACT

s.shah26@aston.ac.uk

+44 121 711 2020

Facility Contacts

Sunil Shah, Phd

Role: primary

s.shah26@aston.ac.uk

0121 667 3251

Other Identifiers

UREC 1524

Identifier Type: -

Identifier Source: org_study_id