ACTIVE_NOT_RECRUITING

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

Conditions

Dry Eye Dry Eye Disease (DED)Dry Eye Disease With Severe Keratitis Dry Eye Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2024-12-12

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06780306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Locations (Sites)

University California Berkeley

Berkeley, California, 94720

United States

Advanced Research, LLC.

Deerfield Beach, Florida, 33064

United States

Southwest Eye Care

Chaska, Minnesota, 55318

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Eye Associates of North Jersey

Dover, New Jersey, 07801

United States

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079

United States

Wilmington Eye at Brunswick Forest

Leland, North Carolina, 28451

United States

CORE, Inc. / Vita Eye Clinic

Shelby, North Carolina, 28150

United States

Westlake Eye Specialists

Austin, Texas, 78749

United States

Collaborators and Investigators

Sponsor: BioTissue Holdings, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Dry Eye Disease

Additional Relevant MeSH Terms

Dry Eye
Dry Eye Disease (DED)
Dry Eye Disease With Severe Keratitis