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

NCT06780306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-02-11

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780306 on ClinicalTrials.gov