Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
Primary Purpose
Dry Eye, Dry Eye Syndromes
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tixel
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Mild to Moderate Periorbital wrinkles
- 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 instructions.
Exclusion Criteria:
- Pregnancy and/or breastfeeding
- Lesions in the periorbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Other concomitant anterior eye disease
- Has undergone outdoors/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 Tixel2 device treatment, or before complete healing of such treatments has occurred.
- Any patient who takes or 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.
- Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
- Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
- Any patient who has tattoos or permanent makeup in the treated area.
- Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- Any patient who underwent thread lifting of the area to be treated in the last 3 months.
Sites / Locations
- Midland EyeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tixel Treatment
Arm Description
Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions
Outcomes
Primary Outcome Measures
NIBUT in Seconds
Non-Invasive Break Up Time
Ocular Surface Disease Index questionnaire
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
SAFETY, number of AEs
Any safety related event during the study will be recorded and analyzed
Secondary Outcome Measures
Topography mm D
Topography with K readings
Slit Lamp Exam; Normal, Abnormal
Multiple Slit Lamp tests
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms.
Lid margin profile
Lid margin profile
Tear Sampling Analysis
ocular tear biomarkers
Staining; Total Ocular Staining Score
Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04730336
Brief Title
Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
Official Title
Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo three sessions of treatments with the Investigation devise
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tixel Treatment
Arm Type
Experimental
Arm Description
Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions
Intervention Type
Device
Intervention Name(s)
Tixel
Other Intervention Name(s)
Fractional
Intervention Description
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
Primary Outcome Measure Information:
Title
NIBUT in Seconds
Description
Non-Invasive Break Up Time
Time Frame
18 Weeks
Title
Ocular Surface Disease Index questionnaire
Description
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
Time Frame
18 Weeks
Title
SAFETY, number of AEs
Description
Any safety related event during the study will be recorded and analyzed
Time Frame
18 Weeks
Secondary Outcome Measure Information:
Title
Topography mm D
Description
Topography with K readings
Time Frame
18 Weeks
Title
Slit Lamp Exam; Normal, Abnormal
Description
Multiple Slit Lamp tests
Time Frame
18 Weeks
Title
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Description
Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms.
Time Frame
18 Weeks
Title
Lid margin profile
Description
Lid margin profile
Time Frame
18 Weeks
Title
Tear Sampling Analysis
Description
ocular tear biomarkers
Time Frame
18 Weeks
Title
Staining; Total Ocular Staining Score
Description
Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Time Frame
18 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Mild to Moderate Periorbital wrinkles
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 instructions.
Exclusion Criteria:
Pregnancy and/or breastfeeding
Lesions in the periorbital area
Acute severe blepharitis
Acute conjunctivitis
Other concomitant anterior eye disease
Has undergone outdoors/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 Tixel2 device treatment, or before complete healing of such treatments has occurred.
Any patient who takes or 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.
Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
Any patient who has tattoos or permanent makeup in the treated area.
Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
Any patient who underwent thread lifting of the area to be treated in the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil Shah, Phd
Phone
+44 121 711 2020
Email
s.shah26@aston.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Shah, Phd
Organizational Affiliation
Midland Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midland Eye
City
Solihull
ZIP/Postal Code
B91 2AW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Shah, Phd
Phone
0121 667 3251
Email
s.shah26@aston.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
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