New eye drops aim to soothe dry eye sufferers
NCT ID NCT06780306
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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74 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Jan 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Advanced Research, LLC.
Deerfield Beach, Florida, 33064, United States
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CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina, 28150, United States
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Eye Associates of North Jersey
Dover, New Jersey, 07801, United States
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Northern New Jersey Eye Institute
South Orange, New Jersey, 07079, United States
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Southwest Eye Care
Chaska, Minnesota, 55318, United States
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University California Berkeley
Berkeley, California, 94720, United States
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University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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Westlake Eye Specialists
Austin, Texas, 78749, United States
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Wilmington Eye at Brunswick Forest
Leland, North Carolina, 28451, United States
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Other studies related to the condition(s) this trial covers.
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