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: * Evaluate the safety of TN-001 * Evaluate whether TN-001 eye drops are well tolerated in and around the eye * Provide an initial indication on whether TN-001 may be effective in treating progressive keratoconus. * Provide an indication of the duration of treatment impact.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Low-dose TGF-B3 and Dexamethasone Sodium Phosphate
High-dose TGF-B3 and Dexamethasone Sodium Phosphate
Ophthalmic Trials Australia
Brisbane, Queensland, Australia
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
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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