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

BioTissue Holdings, Inc

Status and phase: Active, not recruiting; Phase 2

Conditions: Dry Eye; Dry Eye Disease (DED); Dry Eye Disease With Severe Keratitis

Treatments: Biological: TTAX03; Biological: Saline (NaCl 0,9 %) (placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780306

TTAX03-CR010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
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 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

10mg TTAX03 reconstituted in 150 uL saline

Experimental group

Description:

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Treatment:

Biological: TTAX03

10mg TTAX03 reconstituted in 300 uL saline

Active Comparator group

Description:

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Treatment:

Biological: TTAX03

10mg TTAX03 reconstituted in 600 uL saline

Active Comparator group

Description:

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Treatment:

Biological: TTAX03

300 uL of saline

Placebo Comparator group

Description:

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Treatment:

Biological: Saline (NaCl 0,9 %) (placebo)