NCT06780306

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: BioTissue Holdings, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	TTAX03	Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord
BIOLOGICAL	Saline (NaCl 0,9 %) (placebo)	300 mL Sterile, preservative free 0.9% NaCl

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2025-01-17
• Last updated: 2026-02-11

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study