Tixel Treatment for Dry Eye Symptoms

NCT05299619 | Completed DMC

• 1 other identifier: CLN0683
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. Consequences of dry eyes range from subtle but constant eye irritation to significant inflammation and even scarring of the front surface of the eye. Meibomian Gland Dysfunction (MGD) refers to the condition where the glands are not secreting enough oil or when the oil they secrete is of poor quality. Tixel is a fractional skin rejuvenation system, which relies on direct thermal energy delivery, free of any radiation type such as laser, RF, etc. The energy is transferred via a continuously sterile, thermal titanium element (the "Tip"), located on the applicator (the "Handpiece"). In this study, the principal investigator will undertake standard treatment of periorbital wrinkles with Tixel and observe the effect on dry eye disease symptoms and signs.

Conditions

Peri-orbital Wrinkles; Dry Eye

Outcome Measures

Primary Outcomes (2)

• Safety, Device related AE frequency in the study

  Any safety related event during the study will be recorded and analysed

  8 months

• NIBUT in Seconds

  Non-Invasive Break Up Time

  8 months

Secondary Outcomes (3)

• Efficacy assessment - OSDI-Ocular Surface Disease Index Questionnaire changes from baseline

  8 months

• Osmolarity mOsml/L

  8 months

• Staining; Total Ocular Staining Score

  8 month

Study Arms (1)

Tixel Group

EXPERIMENTAL

Tixel treatments in Dry Eye Patients

Device: Tixel

Interventions

Tixel DEVICE

a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling fast water evaporation with low thermal damage to the surrounding tissue (such as charring or ablation).

Also known as: thermomechanical system

Tixel Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• Mild to Moderate Periorbital wrinkles
• OSDI score of at least 23
• Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
• Willing and able to provide written informed consent.
• Willing to participate in all study activities and instructions.

You may not qualify if:

• Pregnancy and breastfeeding
• Lesions in the periorbital area
• Acute severe blepharitis
• Acute conjunctivitis
• Other concomitant anterior eye disease

Sponsors & Collaborators

• Dr Ludger Hanneken: lead

Study Sites (1)

Vallmedic Vision & Aesthetic

Les Escaldes, Andorra

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Model Details: A single-center, prospective, non-masked, pilot study, to assess the safety and efficacy of the Tixel treatment.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: March 29, 2022
• Study Start: March 28, 2019
• Primary Completion: February 22, 2022
• Study Completion: March 28, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)