Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients
- Conditions
- Dry Eye SyndromesDry Eye
- Interventions
- Device: Tixel
- Registration Number
- NCT04260893
- Lead Sponsor
- Novoxel Ltd.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
- ≥ 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.
- 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.
- Tattoos or permanent makeup in the areas to be treated.
- Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- Thread lifting of the area to be treated in the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tixel Treatment Tixel 3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions
- Primary Outcome Measures
Name Time Method SAFETY, number of AEs 8 months Any safety related event during the study will be recorded and analysed
NIBUT in Seconds 8 months Non-Invasive Break Up Time
Ocular Surface Disease Index Questionnaire 8 months OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes
- Secondary Outcome Measures
Name Time Method Tear Meniscus Height mm 8 months Tear Meniscus Height using IDRA device
Lid Wiper Epitheliopathy 8 months Lid Wiper Epitheliopathy
Topography mm D 8 months Topography with K readings
Staining; Total Ocular Staining Score 8 months Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Osmolarity mOsml/L 8 months Osmolarity test with TearLab
Slit Lamp Exam; Normal, Abnormal 8 months Multiple Slit Lamp tests
Meibography % 8 months Calculate Meibography using IDRA device
Trial Locations
- Locations (1)
Khmer Sight Foundation Hospital
🇰🇭Phnom Penh, Cambodia