Study of TN-001 Topical Eyedrops for Keratoconus

Enrolling by invitation · Phase 1/Phase 2

Conditions studied: Keratoconus

In brief

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.

Key facts

Study ID

NCT07388069

Run by

TheiaNova Ltd.

People needed

20

Starts

2025-12-23

Expected to finish

2027-07-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be 18 to 40 years of age inclusive, at the time of signing the informed consent.
• Diagnosed with progressive keratoconus in one or both eyes.
• Minimum corneal thickness equal to or greater than 400 microns.
• Maximum corneal keratometry of 45 D to 54 D.
• Willing and able to comply with all clinic visits and study-related procedures and instructions.
• Able to self-medicate or be assisted with applying study eye drops twice daily for trial duration.
• Provide signed informed consent to participate in the study.

You may not qualify if…

• Concurrent use of contact lenses, including rigid gas permeable lenses
• Known allergy to steroids, growth factors or gellan gum
• Presence of ocular surface inflammation at any screening visit
• Recurrent corneal erosions
• Significant central corneal scarring or hydrops
• Previous corneal cross-linking
• Previous corneal transplant
• Previous corneal or intraocular surgeries
• Presence of any other ocular disease of the eye (not limited to cornea) e.g. glaucoma, uveitis, uncontrolled diabetic retinopathy
• Presence or history of ocular cancer
• Prior ocular trauma or prior retinal detachment involving the macula
• Received an ocular corticosteroid within the past 6 months (within the past 3 months, for topical ocular corticosteroids), or any intravitreal injection within the last 6 months in the study eye prior to day 0
• Any severe comorbid condition or other issue that renders the participant unsuitable for participation in the study
• A comorbid condition with an estimated life expectancy of ≤6 months at the time of consent
• Systemic comorbidities that pose a significant surgical risk
• Current use or anticipated use during the study of a systemic corticosteroid with a dose greater than 10mg daily, or an immunosuppressant agent by any route (oral, injectable)
• Current use or anticipated use during the study of medicated lubricating eye drops or topical ophthalmic antihistamines
• History of connective tissue disorders, collagenoses, collagen vascular diseases, autoimmune or other immune deficiency disease
• Pregnancy or planning to become pregnant
• Participation in another interventional clinical trial within 30 days or 5 half-lives of that Investigational Product prior to consent for this trial, or planning to participate in another clinical trial at the time of consent
• Known alcohol, drug or medication abuse within 1 year prior to consent for this study
• Treatment with an anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or gene therapy) within 3 months prior to day 0 or at any time during the study. Recovery from any associated toxicities must be documented prior to inclusion
• Mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
• Participants who are employees of the Sponsor, study site or their immediate families
• Inability or unwillingness to comply with all follow-up through to the end of the study, and/or unwilling to allow access to review medical records in accordance with local regulatory requirements at the time of consent

Where it is running

• Ophthalmic Trials Australia — Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.