Clinical trial NCT04260893: Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients
Official title: A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye Syndromes
Dry Eye
Lead sponsor: Novoxel Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo three sessions of treatments with the Investigation devise
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: SAFETY, number of AEs
timeFrame: 8 months
measure: NIBUT in Seconds
timeFrame: 8 months
measure: Ocular Surface Disease Index Questionnaire
timeFrame: 8 months
Secondary outcomes:
measure: Topography mm D
timeFrame: 8 months
measure: Staining; Total Ocular Staining Score
timeFrame: 8 months
measure: Osmolarity mOsml/L
timeFrame: 8 months
measure: Slit Lamp Exam; Normal, Abnormal
timeFrame: 8 months
measure: Meibography %
timeFrame: 8 months
measure: Tear Meniscus Height mm
timeFrame: 8 months
measure: Lid Wiper Epitheliopathy
timeFrame: 8 months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Khmer Sight Foundation Hospital
Study officials:
affiliation: University of Puthasastra
name: Sunil Shah, MD
role: STUDY_CHAIR
affiliation: University of Puthasastra
name: Mukesh Taneja, MD
role: PRINCIPAL_INVESTIGATOR
References: