New eye drops aim to halt Vision-Threatening keratoconus

NCT ID NCT07388069

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ophthalmic Trials Australia

    Brisbane, Queensland, 4005, Australia

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