Prospective Study To Assess The Safety And Effectiveness... | NCT04260893

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

NCT04260893

Sponsor

Novoxel Ltd.

Status

Terminated

Last Update Posted

May 7, 2021Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Dry Eye Syndromes
Dry Eye

Interventions

Tixel

Countries

Cambodia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 23, 2020Actual

Primary Completion Date

Mar 13, 2021Actual

Completion Date

Mar 13, 2021Actual

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2021

Last Update Posted Date

May 7, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Label	Type	Description	Intervention Names
Tixel Treatment	Experimental	3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions	Device: Tixel

Name	Type	Description	Arm Group Labels	Other Names
Tixel	Device	Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms	Tixel Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SAFETY, number of AEs	Any safety related event during the study will be recorded and analysed	8 months
NIBUT in Seconds	Non-Invasive Break Up Time	8 months
Ocular Surface Disease Index Questionnaire	OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes	8 months

Secondary Outcomes

Measure	Description	Time Frame
Topography mm D	Topography with K readings	8 months
Staining; Total Ocular Staining Score	Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sunil Shah, MD	University of Puthasastra	Study Chair
Mukesh Taneja, MD	University of Puthasastra	Principal Investigator

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases