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

Primary Purpose

Dry Eye Syndromes, Dry Eye

Status

Terminated

Phase

Not Applicable

Locations

Cambodia

Study Type

Interventional

Intervention

Tixel

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 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.

Exclusion Criteria:

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.

Sites / Locations

Khmer Sight Foundation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tixel Treatment

Arm Description

3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions

Outcomes

Primary Outcome Measures

SAFETY, number of AEs

Any safety related event during the study will be recorded and analysed

NIBUT in Seconds

Non-Invasive Break Up Time

Ocular Surface Disease Index Questionnaire

OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes

Secondary Outcome Measures

Topography mm D

Topography with K readings

Staining; Total Ocular Staining Score

Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

Osmolarity mOsml/L

Osmolarity test with TearLab

Slit Lamp Exam; Normal, Abnormal

Multiple Slit Lamp tests

Meibography %

Calculate Meibography using IDRA device

Tear Meniscus Height mm

Tear Meniscus Height using IDRA device

Lid Wiper Epitheliopathy

Full Information

NCT ID

NCT04260893

First Posted

February 5, 2020

Last Updated

May 4, 2021

Sponsor

Novoxel Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04260893

Brief Title

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

Acronym

DED

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Due to COVID19 adequate study monitoring wasn't possible by the Sponsor

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

March 13, 2021 (Actual)

Study Completion Date

March 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novoxel Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes, Dry Eye

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

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tixel Treatment

Arm Type

Experimental

Arm Description

3 Tixel treatment sessions, 2 weeks apart follow by 3 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

SAFETY, number of AEs

Description

Any safety related event during the study will be recorded and analysed

Time Frame

8 months

Title

NIBUT in Seconds

Description

Non-Invasive Break Up Time

Time Frame

8 months

Title

Ocular Surface Disease Index Questionnaire

Description

OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Topography mm D

Description

Topography with K readings

Time Frame

8 months

Title

Staining; Total Ocular Staining Score

Description

Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

Time Frame

8 months

Title

Osmolarity mOsml/L

Description

Osmolarity test with TearLab

Time Frame

8 months

Title

Slit Lamp Exam; Normal, Abnormal

Description

Multiple Slit Lamp tests

Time Frame

8 months

Title

Meibography %

Description

Calculate Meibography using IDRA device

Time Frame

8 months

Title

Tear Meniscus Height mm

Description

Tear Meniscus Height using IDRA device

Time Frame

8 months

Title

Lid Wiper Epitheliopathy

Description

Lid Wiper Epitheliopathy

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunil Shah, MD

Organizational Affiliation

University of Puthasastra

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mukesh Taneja, MD

Organizational Affiliation

University of Puthasastra

Official's Role

Principal Investigator

Facility Information:

Facility Name

Khmer Sight Foundation Hospital

City

Phnom Penh

Country

Cambodia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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