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

Dry Eye Clinical Trial

— DED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04260893
• Other study ID #: CLN 0734
• Status: Terminated
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: March 13, 2021

Study information

• Verified date: May 2021
• Source: Novoxel Ltd.
• Contact: n/a
• 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 in Asian Patients.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: March 13, 2021
• Est. primary completion date: March 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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
Cambodia	Khmer Sight Foundation Hospital	Phnom Penh

Sponsors (1)

Lead Sponsor	Collaborator
Novoxel Ltd.

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAFETY, number of AEs	Any safety related event during the study will be recorded and analysed	8 months
Primary	NIBUT in Seconds	Non-Invasive Break Up Time	8 months
Primary	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	Topography mm D	Topography with K readings	8 months
Secondary	Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green	8 months
Secondary	Osmolarity mOsml/L	Osmolarity test with TearLab	8 months
Secondary	Slit Lamp Exam; Normal, Abnormal	Multiple Slit Lamp tests	8 months
Secondary	Meibography %	Calculate Meibography using IDRA device	8 months
Secondary	Tear Meniscus Height mm	Tear Meniscus Height using IDRA device	8 months
Secondary	Lid Wiper Epitheliopathy	Lid Wiper Epitheliopathy	8 months