New eye drops aim to halt Vision-Threatening keratoconus
NCT ID NCT07388069
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether TN-001 eye drops are safe and can stop keratoconus, a disease that thins and bulges the cornea, from getting worse. About 20 adults with progressive keratoconus will use the drops twice daily for 3-6 weeks. Researchers will monitor for side effects and check if the treatment stabilizes the cornea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must be 18 to 40 years of age inclusive, at the time of signing the informed consent. 2. Diagnosed with progressive keratoconus in one or both eyes. 3. Minimum corneal thickness equal to or greater than 400 microns. 4. Maximum corneal keratometry of 45 D to 54 D. 5. Willing and able to comply with all clinic visits and study-related procedures and instructions. 6. Able to self-medicate or be assisted with applying study eye drops twice daily for trial duration. 7. Provide signed informed consent to participate in the study. Exclusion Criteria: 1. Concurrent use of contact lenses, including rigid gas permeable lenses 2. Known allergy to steroids, growth factors or gellan gum 3. Presence of ocular surface inflammation at any screening visit 4. Recurrent corneal erosions 5. Significant central corneal scarring or hydrops 6. Previous corneal cross-linking 7. Previous corneal transplant 8. Previous corneal or intraocular surgeries 9. Presence of any other ocular disease of the eye (not limited to cornea) e.g. glaucoma, uveitis, uncontrolled diabetic retinopathy 10. Presence or history of ocular cancer 11. Prior ocular trauma or prior retinal detachment involving the macula 12. 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 13. Any severe comorbid condition or other issue that renders the participant unsuitable for participation in the study 14. A comorbid condition with an estimated life expectancy of ≤6 months at the time of consent 15. Systemic comorbidities that pose a significant surgical risk 16. 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) 17. Current use or anticipated use during the study of medicated lubricating eye drops or topical ophthalmic antihistamines 18. History of connective tissue disorders, collagenoses, collagen vascular diseases, autoimmune or other immune deficiency disease 19. Pregnancy or planning to become pregnant 20. 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 21. Known alcohol, drug or medication abuse within 1 year prior to consent for this study 22. 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 23. Mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study 24. Participants who are employees of the Sponsor, study site or their immediate families 25. 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 26. Retinal disease, including proliferative diabetic retinopathy, retinal fibrosis, neovascular age-related macular degeneration 27. Participants in whom corneal thinning has stabilized by ophthalmologist's opinion during screening 28. Myopic degeneration with potential acuity less than 20/40 in either eye 29. Any reason for which in the opinion of the principal investigator the participant should not be enrolled into the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Keratoconus are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ophthalmic Trials Australia
Brisbane, Queensland, 4005, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Eye scans could spot hidden vision risk in down syndrome
- Can a new eye scanner match the gold standard for cataract surgery?
- Can a Light-Based scan reveal the health of your eyes?
- Can a simple eyeglass test sharpen vision in keratoconus?
- Can a donor corneal lenticule patch up a thinning cornea?
- A piece of your own cornea might patch a thinning one — a trial puts it to the test