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TerminatedNCT04260893DEDUpdated May 7, 2021

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

An interventional study of Tixel in Dry Eye Syndromes and Dry Eye, sponsored by Novoxel Ltd.. Terminated at 1 site in Cambodia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-07.

Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to COVID19 adequate study monitoring wasn't possible by the Sponsor
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Dry Eye Syndromes
  • Dry Eye

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03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Novoxel Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥ 18 years.
  2. OSDI score of at least 23.
  3. Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds.
  4. No other eye or skin or immune problems.
  5. Willing and able to provide written .
  6. Willing to participate in all study activities and follow study instructions.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy and/or breastfeeding.
  2. Lesions in the periorbital area.
  3. Acute severe blepharitis.
  4. Acute conjunctivitis.
  5. Concomitant anterior eye disease.
  6. Has undergone outdoor/sunbed tanning during the last 4 weeks.
  7. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
  8. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
  9. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
  10. An impaired immune system condition or use of medication.
  11. Collagen disorders, keloid formation and/or abnormal wound healing.
  12. 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.
  13. 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.
  14. Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
  15. History of bleeding coagulopathies or use of anticoagulants.
  16. Tattoos or permanent makeup in the areas to be treated.
  17. Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
  18. Thread lifting of the area to be treated in the last 3 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Tixel Treatment

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

    Device: Tixel

Interventions

  • DeviceTixel

    Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

    Also known as: Fractional

06

What researchers measure

Primary outcomes

  1. SAFETY, number of AEs

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

    Time frame: 8 months

  2. NIBUT in Seconds

    Non-Invasive Break Up Time

    Time frame: 8 months

  3. Ocular Surface Disease Index Questionnaire

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

    Time frame: 8 months

Secondary outcomes

  1. Topography mm D

    Topography with K readings

    Time frame: 8 months

  2. Staining; Total Ocular Staining Score

    Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

    Time frame: 8 months

  3. Osmolarity mOsml/L

    Osmolarity test with TearLab

    Time frame: 8 months

  4. Slit Lamp Exam; Normal, Abnormal

    Multiple Slit Lamp tests

    Time frame: 8 months

  5. Meibography %

    Calculate Meibography using IDRA device

    Time frame: 8 months

  6. Tear Meniscus Height mm

    Tear Meniscus Height using IDRA device

    Time frame: 8 months

  7. Lid Wiper Epitheliopathy

    Lid Wiper Epitheliopathy

    Time frame: 8 months

07

Study locations

1 site
  • Khmer Sight Foundation Hospital
    Phnom Penh, Cambodia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Mar 2021, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2020
First posted
Feb 7, 2020
StartActual
Jan 23, 2020
Primary completionActual
Mar 13, 2021
CompletionActual
Mar 13, 2021
Last update
May 7, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04260893
Lead sponsor
Novoxel Ltd.
Responsible party
Sponsor
First posted
Feb 7, 2020
Start date
Jan 23, 2020
Primary completion
Mar 13, 2021
Completion
Mar 13, 2021
Last update
May 7, 2021

Study contacts

Sunil Shah, MD
study chair · University of Puthasastra
Mukesh Taneja, MD
principal investigator · University of Puthasastra

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Dry Eye Syndromes →

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Novoxel Ltd.

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