Study of TN-001 Topical Eyedrops for Keratoconus

NCT07388069 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: TN-001-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratoconus

Keywords

keratoconus; eyedrops; non-invasive; Transforming Growth Factor

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline (Day 1) through Day 180

Secondary Outcomes (6)

• Change from baseline in corneal stiffness and biomechanics

  Baseline (Day 1) to Day 180 of treatment initiation

• Change from baseline in maximum corneal curvature (Kmax)

  Baseline (Day 1) through Day 180

• Change from baseline in mean central corneal curvature

  Baseline (Day 1) through Day 180

• Change from baseline in corneal thickness (pachymetry)

  Baseline (Day 1) through Day 180

• Change from baseline in corneal shape (Belin ABCD parameters)

  Baseline (Day 1) through Day 180

Other Outcomes (2)

• Change from baseline in ocular stiffness parameters measured by Oculus Corvis® ST

  Baseline (Day 1) to Day 180 of treatment initiation

• Change from baseline in corneal parameters associated with disease progression in the treatment eye

  Baseline (Day 1) to Day 180 of treatment initiation

Study Arms (2)

Low-dose

EXPERIMENTAL

Low dose TGF-B3 and Dexamethasone Sodium Phosphate

Drug: Low-dose TGF-B3 and Dexamethasone Sodium Phosphate

High-dose

EXPERIMENTAL

High dose TGF-B3 and Dexamethasone Sodium Phosphate

Drug: High-dose TGF-B3 and Dexamethasone Sodium Phosphate

Interventions

Low-dose TGF-B3 and Dexamethasone Sodium Phosphate DRUG

Low-dose TGF-B3 and Dexamethasone Sodium Phosphate

Low-dose

High-dose TGF-B3 and Dexamethasone Sodium Phosphate DRUG

High-dose TGF-B3 and Dexamethasone Sodium Phosphate

High-dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Recurrent corneal erosions
• Significant central corneal scarring or hydrops
• Previous corneal cross-linking
• Previous corneal transplant
• Previous corneal or intraocular surgeries
• Presence of any other ocular disease of the eye (not limited to cornea) e.g. glaucoma, uveitis, uncontrolled diabetic retinopathy
• Presence or history of ocular cancer
• Prior ocular trauma or prior retinal detachment involving the macula
• 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
• Any severe comorbid condition or other issue that renders the participant unsuitable for participation in the study
• A comorbid condition with an estimated life expectancy of ≤6 months at the time of consent
• Systemic comorbidities that pose a significant surgical risk

Sponsors & Collaborators

• TheiaNova Ltd.: lead

Study Sites (1)

Ophthalmic Trials Australia

Brisbane, Queensland, 4005, Australia

Location

Related Publications (5)

• Diekman BO, Rowland CR, Lennon DP, Caplan AI, Guilak F. Chondrogenesis of adult stem cells from adipose tissue and bone marrow: induction by growth factors and cartilage-derived matrix. Tissue Eng Part A. 2010 Feb;16(2):523-33. doi: 10.1089/ten.TEA.2009.0398.

  PMID: 19715387 BACKGROUND

• CULLEN JF, BUTLER HG. MONGOLISM (DOWN'S SYNDROME) AND KERATOCONUS. Br J Ophthalmol. 1963 Jun;47(6):321-30. doi: 10.1136/bjo.47.6.321. No abstract available.

  PMID: 14189698 BACKGROUND

• Carrington LM, Albon J, Anderson I, Kamma C, Boulton M. Differential regulation of key stages in early corneal wound healing by TGF-beta isoforms and their inhibitors. Invest Ophthalmol Vis Sci. 2006 May;47(5):1886-94. doi: 10.1167/iovs.05-0635.

  PMID: 16638995 BACKGROUND

• Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.

  PMID: 10906086 BACKGROUND

• Ambekar R, Toussaint KC Jr, Wagoner Johnson A. The effect of keratoconus on the structural, mechanical, and optical properties of the cornea. J Mech Behav Biomed Mater. 2011 Apr;4(3):223-36. doi: 10.1016/j.jmbbm.2010.09.014. Epub 2010 Oct 7.

  PMID: 21316609 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two-arm study investigating a low and a high dose of TN-001. A total of 20 participants will be enrolled (ten in each arm).

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 4, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

AU (1)