By InvitationPhase 1/2

Study of TN-001 Topical Eyedrops for Keratoconus

Australia20 participantsStarted 2025-12-23

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant-reported ocular tolerability score (5-point scale)

Timeframe: Baseline (Day 1) to Day 180 of treatment initiation

Incidence of ocular and peri-ocular inflammation by slit-lamp examination

Timeframe: Baseline (Day 1) through Day 180

Incidence of corneal scarring and conjunctival inflammation

Timeframe: Baseline (Day 1) through Day 180

Increase from baseline in intraocular pressure (mmHg)

Timeframe: Baseline (Day 1) through Day 180

Change from baseline in endothelial cell count (cells/mm²)

Timeframe: Baseline (Day 1) through Day 180

Change from baseline in endothelial cell characteristics

Timeframe: Baseline (Day 1) through Day 180

Incidence of structural corneal and ocular surface changes

Timeframe: Baseline (Day 1) through Day 180

Trial details

NCT IDNCT07388069

SponsorTheiaNova Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Keratoconus trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Participant-reported ocular tolerability score (5-point scale)

Timeframe: Baseline (Day 1) to Day 180 of treatment initiation

Incidence of ocular and peri-ocular inflammation by slit-lamp examination

Timeframe: Baseline (Day 1) through Day 180

Incidence of corneal scarring and conjunctival inflammation

Timeframe: Baseline (Day 1) through Day 180

Increase from baseline in intraocular pressure (mmHg)

Timeframe: Baseline (Day 1) through Day 180

Change from baseline in endothelial cell count (cells/mm²)

Timeframe: Baseline (Day 1) through Day 180

Change from baseline in endothelial cell characteristics

Timeframe: Baseline (Day 1) through Day 180

Incidence of structural corneal and ocular surface changes

Timeframe: Baseline (Day 1) through Day 180