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

A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Device: Tixel

Detailed Description

Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of the treatment on dry eye symptoms and signs through multiple

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Khmer Sight Foundation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 18 years.
2. OSDI score of at least 23.
3. Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds.
4. No other eye or skin or immune problems.
5. Willing and able to provide written informed consent.
6. Willing to participate in all study activities and follow study instructions.

Exclusion Criteria:

1. Pregnancy and/or breastfeeding.
2. Lesions in the periorbital area.
3. Acute severe blepharitis.
4. Acute conjunctivitis.
5. Concomitant anterior eye disease.
6. Has undergone outdoor/sunbed tanning during the last 4 weeks.
7. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
8. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
9. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
10. An impaired immune system condition or use of immunosuppressive medication.
11. Collagen disorders, keloid formation and/or abnormal wound healing.
12. 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.
13. 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.
14. Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
15. History of bleeding coagulopathies or use of anticoagulants.
16. Tattoos or permanent makeup in the areas to be treated.
17. Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
18. Thread lifting of the area to be treated in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tixel Treatment; 3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions	Device: Tixel; Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms; Other Names: Fractional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Topography mm D	Topography with K readings	8 months
Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green	8 months
Osmolarity mOsml/L	Osmolarity test with TearLab	8 months
Slit Lamp Exam; Normal, Abnormal	Multiple Slit Lamp tests	8 months
Meibography %	Calculate Meibography using IDRA device	8 months
Tear Meniscus Height mm	Tear Meniscus Height using IDRA device	8 months
Lid Wiper Epitheliopathy	Lid Wiper Epitheliopathy	8 months

Collaborators and Investigators

• Sponsor: Novoxel Ltd.
• Investigators: Study Chair: Sunil Shah, MD, University of Puthasastra; Principal Investigator: Mukesh Taneja, MD, University of Puthasastra

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): March 13, 2021
• Study Completion (Actual): March 13, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CLN 0734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No