drugset / Trial / NCT06780306

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

NCT06780306 ↗

Phase 2 Completed 74 enrolled BioTissue Holdings, Inc
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-12-12
Primary completion
2026-01-30
Completion
2026-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject TTAX03 Other / unclassified 10 mg Other

Indications