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

Last updated: February 28, 2025
Sponsor: BioTissue Holdings, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Sjogren's Syndrome

Dry Eye Disease

Eye Disorders/infections

Treatment

Saline (NaCl 0,9 %) (placebo)

TTAX03

Clinical Study ID

NCT06780306
TTAX03-CR010
  • Ages > 18
  • All Genders

Study Summary

The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED.

The primary question it aims to answer is if TTAX03 is safe. The secondary is the effectiveness.

Researchers will compare 10mg of TTAX03 reconstituted in 150, 300, or 600 uL saline to the saline control group to look at effectiveness.

Participants will be randomized to a treatment group one time and be evaluated at 5 different study visits.

Eligibility Criteria

Inclusion

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 atleast one region, by the NEI Grading System† in the study eye.

  6. In the opinion of the investigator, the participant can follow oral and writteninstructions.

  7. In the opinion of the investigator, the participant can complete all studyprocedures and visits.

Exclusion

Exclusion Criteria:

  1. Has a corneal ectatic disorder or other ocular surface disease such as limbal stemcell deficiency or a cicatricial component (e.g., symblepharon, fornixforeshortening and lid margin/lashes abnormality) caused for example by oGVHD,irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermalnecrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival gobletcells (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) orhistory 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 orulcer in either eye.

  9. Has severe DED per corneal fluorescein staining with a total score > 13 by theNEI 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 toscreening.

  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 timecourse 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 researchstudy that in the opinion of the investigator would confound or would riskconfounding study results.

  23. Has a condition or is in a situation which, in the investigator's opinion, may putthe participant at significant risk, may confound study outcomes, or maysignificantly interfere with the participant's participation in the study.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Saline (NaCl 0,9 %) (placebo)
Phase: 2
Study Start date:
December 12, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED. After confirmation of inclusion and exclusion criteria, all eligible patients will be randomized in a 1:1:1:1 ratio to receive one of the three doses of TTAX03 (10 mg of TTAX03 reconstituted in 150, 300, or 600 uL saline, i.e., subgroup A, B, and C, respectively) or to the saline control group (subgroup D). For all four groups, the same volume of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the eye. The more severe eye will serve as the study eye, which meets inclusion and exclusion criteria. The treatment period is 5 days of continuous bandage contact lens wear. Safety follow-up without further treatment will continue for twelve weeks. After baseline (day

  1. and completion of treatment, enrolled patients will be evaluated for safety and efficacy at Day 6 ± 1, Day 29 ± 3, Day 57 ± 3, and Day 85 ± 3.

Connect with a study center

  • Eye Associates of North Jersey

    Dover, New Jersey 07801
    United States

    Active - Recruiting

  • Northern New Jersey Eye Institute

    South Orange, New Jersey 07079
    United States

    Active - Recruiting

  • Wilmington Eye at Brunswick Forest

    Leland, North Carolina 28451
    United States

    Active - Recruiting

  • CORE, Inc. / Vita Eye Clinic

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

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