KeratoconusPhase 1/2NCT07388069
Study of TN-001 Topical Eyedrops for Keratoconus
A Phase 1/2 study testing Low-dose TGF-B3 and Dexamethasone Sodium Phosphate and High-dose TGF-B3 and Dexamethasone Sodium Phosphate in people with Keratoconus, run by TheiaNova Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Low-dose TGF-B3 and Dexamethasone Sodium Phosphate and High-dose TGF-B3 and Dexamethasone Sodium Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Dec 2025to 1 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 29Show fewer
- 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
- Current use or anticipated use during the study of a systemic corticosteroid with a dose greater than 10mg daily, or an immunosuppressant agent by any route (oral, injectable)
- Current use or anticipated use during the study of medicated lubricating eye drops or topical ophthalmic antihistamines
- History of connective tissue disorders, collagenoses, collagen vascular diseases, autoimmune or other immune deficiency disease
- Pregnancy or planning to become pregnant
- Participation in another interventional clinical trial within 30 days or 5 half-lives of that Investigational Product prior to consent for this trial, or planning to participate in another clinical trial at the time of consent
- Known alcohol, drug or medication abuse within 1 year prior to consent for this study
- Treatment with an anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or gene therapy) within 3 months prior to day 0 or at any time during the study. Recovery from any associated toxicities must be documented prior to inclusion
- Mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Participants who are employees of the Sponsor, study site or their immediate families
- Inability or unwillingness to comply with all follow-up through to the end of the study, and/or unwilling to allow access to review medical records in accordance with local regulatory requirements at the time of consent
- Retinal disease, including proliferative diabetic retinopathy, retinal fibrosis, neovascular age-related macular degeneration
- Participants in whom corneal thinning has stabilized by ophthalmologist's opinion during screening
- Myopic degeneration with potential acuity less than 20/40 in either eye
- Any reason for which in the opinion of the principal investigator the participant should not be enrolled into the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Proof of Concept, Open-label, Two-arm Study to Investigate the Safety and Preliminary Efficacy of TN-001 Topical Eyedrops in Male and Female Patients With Progressive Keratoconus.
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.
Read the detailed description
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.
- Conditions
- Keratoconus
- Being tested
- Low-dose TGF-B3 and Dexamethasone Sodium Phosphate, High-dose TGF-B3 and Dexamethasone Sodium Phosphate
- Keywords
- keratoconus, eyedrops, non-invasive, Transforming Growth Factor
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose TGF-B3 and Dexamethasone Sodium PhosphateDrug
Low-dose TGF-B3 and Dexamethasone Sodium Phosphate
High-dose TGF-B3 and Dexamethasone Sodium PhosphateDrug
High-dose TGF-B3 and Dexamethasone Sodium Phosphate
| Study group | Role | What they receive |
|---|---|---|
| Low-dose | Experimental | Low dose TGF-B3 and Dexamethasone Sodium Phosphate Receives: Drug: Low-dose TGF-B3 and Dexamethasone Sodium Phosphate |
| High-dose | Experimental | High dose TGF-B3 and Dexamethasone Sodium Phosphate Receives: Drug: High-dose TGF-B3 and Dexamethasone Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) through Day 180
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) through Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start23 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TheiaNova Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388069
- Sponsor's protocol ID
- TN-001-01
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19715387CULLEN 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.
PubMed 14189698Carrington 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.
PubMed 16638995Bawazeer 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.
PubMed 10906086Ambekar 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.
PubMed 21316609
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Open-label, Two-arm Study to Investigate the Safety and Preliminary Efficacy of TN-001 Topical Eyedrops in Male and Female Patients With Progressive Keratoconus.
- ClinicalTrials.gov ID
- NCT07388069
- Acronym / sponsor ID
- TN-001-01
- Conditions
- Keratoconus
- Keywords
- keratoconus, eyedrops, non-invasive, Transforming Growth Factor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TheiaNova Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low-dose | Experimental | Drug: Low-dose TGF-B3 and Dexamethasone Sodium PhosphateLow dose TGF-B3 and Dexamethasone Sodium Phosphate |
| High-dose | Experimental | Drug: High-dose TGF-B3 and Dexamethasone Sodium PhosphateHigh dose TGF-B3 and Dexamethasone Sodium Phosphate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose TGF-B3 and Dexamethasone Sodium PhosphateLow-dose TGF-B3 and Dexamethasone Sodium Phosphate | Drug | Low-dose |
| High-dose TGF-B3 and Dexamethasone Sodium PhosphateHigh-dose TGF-B3 and Dexamethasone Sodium Phosphate | Drug | High-dose |
Primary outcome
Participant-reported ocular tolerability score (5-point scale)
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Participant-reported ocular tolerability was assessed using a study-specific eye questionnaire measured on a 5-point ordinal scale in the treatment eye.
Incidence of ocular and peri-ocular inflammation by slit-lamp examination
Time frame: Baseline (Day 1) through Day 180
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.
Incidence of corneal scarring and conjunctival inflammation
Time frame: Baseline (Day 1) through Day 180
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.
Increase from baseline in intraocular pressure (mmHg)
Time frame: Baseline (Day 1) through Day 180
Increase from baseline in intraocular pressure measured using a hand-held tonometer (mmHg) in the treatment eye.
Change from baseline in endothelial cell count (cells/mm²)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in endothelial cell count measured using specular microscopy (cells/mm²) in the treatment eye.
Change from baseline in endothelial cell characteristics
Time frame: Baseline (Day 1) through Day 180
Change from baseline in endothelial cell characteristics, including coefficient of variation and percentage of hexagonal cells, measured using specular microscopy in the treatment eye.
Incidence of structural corneal and ocular surface changes
Time frame: Baseline (Day 1) through Day 180
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.
Change from baseline in stromal thickness (microns)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in stromal thickness measured in microns using anterior segment optical coherence tomography in the treatment eye.
Change from baseline in choroidal and retinal thickness
Time frame: Baseline (Day 1) through Day 180
Change from baseline in choroidal and retinal thickness measured using optical coherence tomography in the treatment eye.
Incidence of abnormal findings on dilated fundus examination
Time frame: Baseline (Day 1) through Day 180
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.
Change from baseline in visual acuity (LogMAR)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in visual acuity measured using a LogMAR chart in the treatment eye.
6 secondary outcomes
Change from baseline in corneal stiffness and biomechanics
Time frame: Baseline (Day 1) to Day 180 of treatment initiation
Change from baseline in maximum corneal curvature (Kmax)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in mean central corneal curvature
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal thickness (pachymetry)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal shape (Belin ABCD parameters)
Time frame: Baseline (Day 1) through Day 180
Change from baseline in corneal higher-order aberrations
Time frame: Baseline (Day 1) through Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 19715387Diekman 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.
- Background: PubMed 14189698CULLEN 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.
- Background: PubMed 16638995Carrington 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.
- Background: PubMed 10906086Bawazeer 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.
- Background: PubMed 21316609Ambekar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low-dose TGF-B3 and Dexamethasone Sodium Phosphate and High-dose TGF-B3 and Dexamethasone Sodium Phosphate in people with Keratoconus, run by TheiaNova Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported ocular tolerability score (5-point scale) (time frame: Baseline (Day 1) to Day 180 of treatment initiation). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388069, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.