A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03.

Launched by BIOTISSUE HOLDINGS, INC · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called TTAX03 for people suffering from mild to moderate dry eye disease (DED). The researchers want to find out if TTAX03 is safe and effective compared to saline, a common saltwater solution used in eye treatments. Participants will be randomly assigned to receive either TTAX03 or saline during the study, which includes five visits to the clinic for evaluations.

To be eligible for this trial, participants must be at least 18 years old and have specific dryness and discomfort scores related to their eyes. It's important that they can follow directions and complete all study visits. However, certain eye conditions and recent treatments might disqualify someone from participating. This study is currently recruiting participants, and those who join will have the opportunity to help researchers learn more about new ways to treat dry eye disease.

Gender

ALL

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.