Dry Eye SyndromesDEDNCT04260893
Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients
A study testing Tixel in people with Dry Eye Syndromes and Dry Eye, run by Novoxel Ltd. at 1 site in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye
- What is being tested?
- Tixel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCambodia
- Study dates
- 23 Jan 2020to 13 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye
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.
Read the 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
- Conditions
- Dry Eye Syndromes, Dry Eye
- Being tested
- Tixel
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TixelDevice
Also called Fractional
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
| Study group | Role | What they receive |
|---|---|---|
| Tixel Treatment | Experimental | 3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions Receives: Device: Tixel |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY, number of AEs
Any safety related event during the study will be recorded and analysed
Measured: 8 months
NIBUT in Seconds
Non-Invasive Break Up Time
Measured: 8 months
Ocular Surface Disease Index Questionnaire
OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes
Measured: 8 months
Secondary outcomes (7)
Topography mm D
Topography with K readings
Measured: 8 months
Staining; Total Ocular Staining Score
Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Measured: 8 months
Osmolarity mOsml/L
Osmolarity test with TearLab
Measured: 8 months
Slit Lamp Exam; Normal, Abnormal
Multiple Slit Lamp tests
Measured: 8 months
Meibography %
Calculate Meibography using IDRA device
Measured: 8 months
Tear Meniscus Height mm
Tear Meniscus Height using IDRA device
Measured: 8 months
Lid Wiper Epitheliopathy
Lid Wiper Epitheliopathy
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start23 Jan 2020
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
Why it stopped: Due to COVID19 adequate study monitoring wasn't possible by the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo three sessions of treatments with the Investigation devise
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novoxel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil Shah, MD, Study chair, University of PuthasastraMukesh Taneja, MD, Principal investigator, University of Puthasastra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260893
- Sponsor's protocol ID
- CLN 0734
- Acronym
- DED
- Status last verified
- May 2021
- First submitted
- 5 Feb 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT04260893
- Acronym / sponsor ID
- DED / CLN 0734
- Conditions
- Dry Eye Syndromes, Dry Eye
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID19 adequate study monitoring wasn't possible by the Sponsor
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novoxel Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo three sessions of treatments with the Investigation devise
| Arm | Type | Receives |
|---|---|---|
| Tixel Treatment | Experimental | Device: Tixel3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (18 listed)
- Pregnancy and/or breastfeeding.
- Lesions in the periorbital area.
- Acute severe blepharitis.
- Acute conjunctivitis.
- Concomitant anterior eye disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TixelAlso: FractionalPeri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms | Device | Tixel Treatment |
Primary outcome
SAFETY, number of AEs
Time frame: 8 months
Any safety related event during the study will be recorded and analysed
NIBUT in Seconds
Time frame: 8 months
Non-Invasive Break Up Time
Ocular Surface Disease Index Questionnaire
Time frame: 8 months
OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes
7 secondary outcomes
Topography mm D
Time frame: 8 months
Staining; Total Ocular Staining Score
Time frame: 8 months
Osmolarity mOsml/L
Time frame: 8 months
Slit Lamp Exam; Normal, Abnormal
Time frame: 8 months
Meibography %
Time frame: 8 months
Tear Meniscus Height mm
Time frame: 8 months
Lid Wiper Epitheliopathy
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Due to COVID19 adequate study monitoring wasn't possible by the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Shah, MD study chair
University of Puthasastra
Mukesh Taneja, MD principal investigator
University of Puthasastra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel in people with Dry Eye Syndromes and Dry Eye, run by Novoxel Ltd. at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID19 adequate study monitoring wasn't possible by the Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAFETY, number of AEs (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.