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

NCT06780306 | Completed Phase 2 FDA Drug

• 1 other identifier: TTAX03-CR010
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Determine 12 week ocular and general safety after application of TTAX03.

  Incidence and nature of treatment emergent adverse events (TEAE) between TTAX03 and saline.

  12 weeks

Secondary Outcomes (24)

• Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 6 by group.

  Day 6

• Mean change from baseline to Day 6 in corneal fluorescein staining (National Eye Institute (NEI) score) by group.

  Baseline to Day 6

• Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 6 by group.

  Baseline to Day 6

• Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 29 by group.

  Baseline to Day 29

• Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 57 by group.

  Baseline to Day 57

Study Arms (4)

10mg TTAX03 reconstituted in 150 uL saline

EXPERIMENTAL

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.

Biological: TTAX03

10mg TTAX03 reconstituted in 300 uL saline

ACTIVE COMPARATOR

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.

Biological: TTAX03

10mg TTAX03 reconstituted in 600 uL saline

ACTIVE COMPARATOR

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.

Biological: TTAX03

300 uL of saline

PLACEBO COMPARATOR

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.

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

Interventions

TTAX03 BIOLOGICAL

Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord

10mg TTAX03 reconstituted in 150 uL saline; 10mg TTAX03 reconstituted in 300 uL saline; 10mg TTAX03 reconstituted in 600 uL saline

Saline (NaCl 0,9 %) (placebo) BIOLOGICAL

300 mL Sterile, preservative free 0.9% NaCl

300 uL of saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Provision of signed and dated informed consent form.
• Baseline VAS Dryness score ≥40
• Baseline Ocular Surface Disease Index (OSDI) score ≥ 13.
• 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.
• In the opinion of the investigator, the participant can follow oral and written instructions.
• In the opinion of the investigator, the participant can complete all study procedures and visits.

You may not qualify if:

• 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).
• Has severe blepharitis or severe obvious inflammation of the lid margin.
• Has severe conjunctivochalasis.
• Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid.
• Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) or history of recurrent corneal erosion
• Has neuropathic corneal pain
• Has a sunken globe (due to the reduction or loss of orbital fat)
• Has severe DED per corneal fluorescein staining with a total score ≥ 13by the NEI Grading System in either eye.
• Prior history of intolerance or adverse events using BCL.
• Have had dissolvable or temporary plug(s) (including hydrogel or Lacrifill®) inserted within 6 months prior to screening.
• Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days.
• Has had previous ocular surgery in the study eye within the past 12 weeks.
• Plans to use autologous serum drops during the study period in either eye.
• Has elevated intraocular pressure \>21mmHg in either eye requiring topical therapy.
• Is currently using or plans to use topical glaucoma medication in either eye.

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (9)

University California Berkeley

Berkeley, California, 94720, United States

Location

Advanced Research, LLC.

Deerfield Beach, Florida, 33064, United States

Location

Southwest Eye Care

Chaska, Minnesota, 55318, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Eye Associates of North Jersey

Dover, New Jersey, 07801, United States

Location

Northern New Jersey Eye Institute

South Orange, New Jersey, 07079, United States

Location

Wilmington Eye at Brunswick Forest

Leland, North Carolina, 28451, United States

Location

CORE, Inc. / Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Westlake Eye Specialists

Austin, Texas, 78749, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: December 12, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-09

Locations

US (9)