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

Eligibility 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.
• 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.