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 range18 Years – 40 Years

SexALL

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

✕. 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

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

Change from baseline in stromal thickness (microns)

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 range18 Years – 40 Years

SexALL

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

✕. 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

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

Change from baseline in stromal thickness (microns)