NCT07388069

Study of TN-001 Topical Eyedrops for Keratoconus

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.

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: TheiaNova Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TN-001, the study drug, is a topical eyedrop containing Transforming Growth Factor Beta 3 (TGFB3) and Dexamethasone Sodium Phosphate (DexSP). It is anticipated that TN-001 may produce collagen in the eye, which is believed to stiffen the cornea. Stiffening of the cornea is desirable in patients with keratoconus as it helps to stop disease progression. The purpose of this study is to: * Evaluate the safety of TN-001 * Evaluate whether TN-001 eye drops are well tolerated in and around the eye * Provide an initial indication on whether TN-001 may be effective in treating progressive keratoconus. * Provide an indication of the duration of treatment impact.

Conditions

• Keratoconus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-12-31
• Completion: 2027-07-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Australia