Comparing TTAX03 to saline for treating mild to moderate dry eye disease

A Phase 2 Randomized, Controlled, Multicenter, Dose Optimization Study of TTAX03 in the Treatment of Mild to Moderate Dry Eye Disease (DED)

This study is testing a new treatment called TTAX03 for people with mild to moderate dry eye disease to see if it works better than a saline solution.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioTissue Holdings, Inc (Industry-sponsored)
• Locations: 4 sites (Dover, New Jersey and 3 other locations)
• Trial ID: NCT06780306 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, multicenter study aims to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate dry eye disease (DED). Eligible patients will be randomly assigned to receive one of three doses of TTAX03 or a saline control, with treatment administered via a bandage contact lens. The study will involve five visits over a treatment period of five days, followed by a twelve-week safety follow-up. The primary focus is on the safety of TTAX03, while secondary outcomes will assess its effectiveness compared to saline.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific baseline scores indicating mild to moderate dry eye disease.

Not a fit: Patients with severe ocular surface diseases or corneal ectatic disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from mild to moderate dry eye disease.

How similar studies have performed: Other studies have explored treatments for dry eye disease, but the specific approach of using TTAX03 is novel.

Eligibility criteria

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 but ≤ 32.
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 defined by OSDI ≥ 33 and/or presence of corneal epithelial defect or ulcer in either eye.
9. Has severe DED per corneal fluorescein staining with a total score \> 13 by the NEI Grading System† in either eye.
10. Prior history of intolerance or adverse events using BCL.
11. Have had hydrogel or other dissolvable plugs inserted within 4 weeks prior to screening.
12. Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days.
13. Has had previous ocular surgery within the past 12 weeks.
14. Plans to use autologous serum drops during the study period in either eye.
15. Has elevated intraocular pressure in either eye requiring topical therapy.
16. Is currently using or plans to use topical glaucoma medication in either eye.
17. Has a known allergy to topical ophthalmic sodium fluorescein dye.
18. Has a known intolerance to unbuffered normal saline.
19. Prior adverse events of using human birth tissue product.
20. Is currently incarcerated or anticipates possible incarceration during the time course of this study.
21. Has tested positive for COVID-19 within 28 days prior to screening.
22. 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.
23. 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.

Where this trial is running

Dover, New Jersey and 3 other locations

• Eye Associates of North Jersey — Dover, New Jersey, United States (Recruiting)
• Northern New Jersey Eye Institute — South Orange, New Jersey, United States (Recruiting)
• Wilmington Eye at Brunswick Forest — Leland, North Carolina, United States (Recruiting)
• CORE, Inc. / Vita Eye Clinic — Shelby, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Director Clinical Operations

Conditions Dry Eye; Dry Eye Disease; Dry Eye Disease With Severe Keratitis