A Phase 1/2 interventional study of Low-dose TGF-B3 and Dexamethasone Sodium Phosphate and High-dose TGF-B3 and Dexamethasone Sodium Phosphate in Keratoconus, sponsored by TheiaNova Ltd.. Enrolling by invitation at 1 site in Australia. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by TheiaNova Ltd. · Phase 1/2, Interventional, and Treatment
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.
TN-001, the study drug, is a topical eyedrop containing Transforming Growth Factor Beta 3 (TGFB3) and Dexamethasone Sodium Phosphate (DexSP). It is anticipated that TN-001 may produce collagen in the eye, which is believed to stiffen the cornea. Stiffening of the cornea is desirable in patients with keratoconus as it helps to stop disease progression.
The purpose of this study is to:
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with TheiaNova Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose TGF-B3 and Dexamethasone Sodium Phosphate
Drug: Low-dose TGF-B3 and Dexamethasone Sodium Phosphate
High dose TGF-B3 and Dexamethasone Sodium Phosphate
Drug: High-dose TGF-B3 and Dexamethasone Sodium Phosphate
Drug page: Dexamethasone phosphate
Low-dose TGF-B3 and Dexamethasone Sodium Phosphate
Drug page: Dexamethasone phosphate
High-dose TGF-B3 and Dexamethasone Sodium Phosphate
Participant-reported ocular tolerability score (5-point scale)
Participant-reported ocular tolerability was assessed using a study-specific eye questionnaire measured on a 5-point ordinal scale in the treatment eye.
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Incidence of ocular and peri-ocular inflammation by slit-lamp examination
Incidence of inflammation of the eye and surrounding tissues, including redness, aqueous cells, flare, limbus, fornices, tear ducts, and meibomian glands, assessed by slit-lamp microscopy using the Efron scale or a similar numerical grading scale in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Incidence of corneal scarring and conjunctival inflammation
Incidence of corneal scarring and conjunctival inflammation assessed by slit-lamp microscopy using the Efron scale or a similar numerical grading scale in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Increase from baseline in intraocular pressure (mmHg)
Increase from baseline in intraocular pressure measured using a hand-held tonometer (mmHg) in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in endothelial cell count (cells/mm²)
Change from baseline in endothelial cell count measured using specular microscopy (cells/mm²) in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in endothelial cell characteristics
Change from baseline in endothelial cell characteristics, including coefficient of variation and percentage of hexagonal cells, measured using specular microscopy in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Incidence of structural corneal and ocular surface changes
Incidence of structural changes of the cornea and ocular surface, including corneal opacities, corneal haze, and keratitis, assessed by anterior segment optical coherence tomography in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in stromal thickness (microns)
Change from baseline in stromal thickness measured in microns using anterior segment optical coherence tomography in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in choroidal and retinal thickness
Change from baseline in choroidal and retinal thickness measured using optical coherence tomography in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Incidence of abnormal findings on dilated fundus examination
Incidence of pathology involving the retina, optic nerve, lens, and/or macula assessed by dilated fundus examination using slit-lamp microscopy with a fundus lens in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in visual acuity (LogMAR)
Change from baseline in visual acuity measured using a LogMAR chart in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal stiffness and biomechanics
Change from baseline in corneal stiffness and biomechanical parameters measured using the Oculus Corvis® ST in the treatment eye.
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Change from baseline in maximum corneal curvature (Kmax)
Change from baseline in maximum corneal curvature measured using central keratometry (Kmax) with the Oculus Pentacam in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in mean central corneal curvature
Change from baseline in mean central corneal curvature measured using keratometry with the Oculus Pentacam in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal thickness (pachymetry)
Change from baseline in corneal thickness (pachymetry), measured in microns using the Oculus Pentacam in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal shape (Belin ABCD parameters)
Change from baseline in corneal shape assessed using Belin ABCD parameters measured with the Oculus Pentacam in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal higher-order aberrations
Change from baseline in corneal higher-order aberrations, including spherical and coma-like aberrations, measured using Pentacam wavefront aberrometry in the treatment eye.
Time frame: Baseline (Day 1) through Day 180
Change from baseline in ocular stiffness parameters measured by Oculus Corvis® ST
Change from baseline in ocular stiffness parameters in participants with keratoconus, measured using the Oculus Corvis® ST in the treatment eye, to evaluate persistence of biomechanical changes through Day 180. The specific parameters assessed include: * Stiffness Parameter at First Applanation (SP-A1, N/m) * Stiffness Parameter at Highest Concavity (SP-HC, N/m) * Deformation Amplitude Ratio at 2 mm (DA Ratio 2 mm, ratio) * Integrated Inverse Radius (m-¹) * Stress-Strain Index (SSI, range 0-1)
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Change from baseline in corneal parameters associated with disease progression in the treatment eye
Change from baseline in corneal parameters associated with disease progression in the treatment eye in participants with keratoconus, evaluated through Day 180. The specific measurements assessed include: Corneal curvature (keratometry): * Maximum keratometry (Kmax, diopters) * Zonal maximum keratometry (Zonal Kmax, diopters) Corneal thickness (pachymetry): \- Corneal thickness (microns) Corneal shape (topography): \- Belin ABCD classification parameters (continuous measures) Corneal aberrations: * Root Mean Square (RMS) total aberrations (µm) * RMS low-order aberrations (LOA, µm) * RMS high-order aberrations (HOA, µm) * HOA spherical aberration (µm) * HOA coma aberration (µm)
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Plan to share: Undecided
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
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Studies of the drug tested here: Dexamethasone phosphate