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

NCT ID: NCT04260893

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2021-03-13

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.

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

Conditions

Dry Eye Syndromes; Dry Eye

Study Design

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

Study Groups

Tixel Treatment

3 Tixel treatment sessions, 2 weeks apart follow by 3 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

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.

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

Sponsors

Novoxel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Shah, MD

Role: STUDY_CHAIR

University of Puthasastra

Mukesh Taneja, MD

Role: PRINCIPAL_INVESTIGATOR

University of Puthasastra

Locations

Khmer Sight Foundation Hospital

Phnom Penh, , Cambodia

Countries

Cambodia

Other Identifiers

CLN 0734

Identifier Type: -

Identifier Source: org_study_id