Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients

NCT04260893 | Terminated

• 1 other identifier: CLN 0734
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 in Asian Patients.

Conditions

Dry Eye Syndromes; Dry Eye

Outcome Measures

Primary Outcomes (3)

• SAFETY, number of AEs

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

  8 months

• NIBUT in Seconds

  Non-Invasive Break Up Time

  8 months

• Ocular Surface Disease Index Questionnaire

  OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes

  8 months

Secondary Outcomes (7)

• Topography mm D

  8 months

• Staining; Total Ocular Staining Score

  8 months

• Osmolarity mOsml/L

  8 months

• Slit Lamp Exam; Normal, Abnormal

  8 months

• Meibography %

  8 months

Study Arms (1)

Tixel Treatment

EXPERIMENTAL

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

Device: Tixel

Interventions

Tixel DEVICE

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

Also known as: Fractional

Tixel Treatment

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years.
• 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 follow study instructions.

You may not qualify if:

• Pregnancy and/or breastfeeding.
• Lesions in the periorbital area.
• Acute severe blepharitis.
• Acute conjunctivitis.
• Concomitant anterior eye disease.
• Has undergone outdoor/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 Tixel treatments, or before complete healing of the treatments has occurred.
• 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.
• Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
• History of bleeding coagulopathies or use of anticoagulants.

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (1)

Khmer Sight Foundation Hospital

Phnom Penh, Cambodia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sunil Shah, MD

  University of Puthasastra

  STUDY CHAIR

• Mukesh Taneja, MD

  University of Puthasastra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will undergo three sessions of treatments with the Investigation devise

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: January 23, 2020
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)