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ENROLLING BY INVITATION
NCT07388069
PHASE1/PHASE2

Study of TN-001 Topical Eyedrops for Keratoconus

Sponsor: TheiaNova Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if TN-001, a new eye-drop therapy, is safe and well-tolerated in adult patients with progressive keratoconus. It will also provide data on whether this therapy is effective in treating keratoconus. The main questions it aims to answer are: What medical problems do participants have when using TN-001 eyedrops? Does TN-001 eyedrop therapy stop keratoconus from progressing further? Participants will: Take TN-001 eyedrops twice a day, every day, for 3-6 weeks. Visit the clinic once every week for checkups and tests. Keep a diary of their symptoms.

Official title: A Proof of Concept, Open-label, Two-arm Study to Investigate the Safety and Preliminary Efficacy of TN-001 Topical Eyedrops in Male and Female Patients With Progressive Keratoconus.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-12-23

Completion Date

2027-07-01

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Low-dose TGF-B3 and Dexamethasone Sodium Phosphate

Low-dose TGF-B3 and Dexamethasone Sodium Phosphate

DRUG

High-dose TGF-B3 and Dexamethasone Sodium Phosphate

High-dose TGF-B3 and Dexamethasone Sodium Phosphate

Locations (1)

Ophthalmic Trials Australia

Brisbane, Queensland, Australia