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New eye drops aim to soothe dry eye sufferers

NCT ID NCT06780306

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new eye treatment called TTAX03 in 74 people with mild to moderate dry eye disease. The goal was to see if it is safe and if it can reduce eye dryness and damage. Participants received either a single dose of TTAX03 or a saline (salt water) control and were checked over 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

74 people

The number who actually took part.

Started

Dec 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Provision of signed and dated informed consent form. 3. Baseline VAS Dryness score ≥40 4. Baseline Ocular Surface Disease Index (OSDI) score ≥ 13. 5. Baseline corneal fluorescein staining with a total score ≥ 4 but ≤13, and ≥ 2 in at least one region, by the NEI Grading System† in the study eye. 6. In the opinion of the investigator, the participant can follow oral and written instructions. 7. In the opinion of the investigator, the participant can complete all study procedures and visits. Exclusion Criteria: 1. Has a corneal ectatic disorder or other ocular surface disease such as limbal stem cell deficiency or a cicatricial component (e.g., symblepharon, fornix foreshortening and lid margin/lashes abnormality) caused for example by oGVHD, irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermal necrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival goblet cells (as with vitamin A deficiency). 2. Has severe blepharitis or severe obvious inflammation of the lid margin. 3. Has severe conjunctivochalasis. 4. Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid. 5. Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) or history of recurrent corneal erosion 6. Has neuropathic corneal pain 7. Has a sunken globe (due to the reduction or loss of orbital fat) 8. Has severe DED per corneal fluorescein staining with a total score ≥ 13by the NEI Grading System in either eye. 9. Prior history of intolerance or adverse events using BCL. 10. Have had dissolvable or temporary plug(s) (including hydrogel or Lacrifill®) inserted within 6 months prior to screening. 11. Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days. 12. Has had previous ocular surgery in the study eye within the past 12 weeks. 13. Plans to use autologous serum drops during the study period in either eye. 14. Has elevated intraocular pressure \>21mmHg in either eye requiring topical therapy. 15. Is currently using or plans to use topical glaucoma medication in either eye. 16. Has a known allergy to topical ophthalmic sodium fluorescein dye. 17. Has a known intolerance to unbuffered normal saline. 18. Prior adverse events of using human birth tissue product. 19. Is currently incarcerated or anticipates possible incarceration during the time course of this study. 20. Has tested positive for COVID-19 within 28 days prior to screening. 21. Is currently participating in any other type of eye-related clinical or research study that in the opinion of the investigator would confound or would risk confounding study results. 22. Has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound study outcomes, or may significantly interfere with the participant's participation in the study. 23. Prior amniotic membrane product used for dry eye therapy in the study eye in the past 6 months. 24. Has Strabismus (squint/crossed eyes) or Amblyopia (lazy eye).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advanced Research, LLC.

    Deerfield Beach, Florida, 33064, United States

  • CORE, Inc. / Vita Eye Clinic

    Shelby, North Carolina, 28150, United States

  • Eye Associates of North Jersey

    Dover, New Jersey, 07801, United States

  • Northern New Jersey Eye Institute

    South Orange, New Jersey, 07079, United States

  • Southwest Eye Care

    Chaska, Minnesota, 55318, United States

  • University California Berkeley

    Berkeley, California, 94720, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Westlake Eye Specialists

    Austin, Texas, 78749, United States

  • Wilmington Eye at Brunswick Forest

    Leland, North Carolina, 28451, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.