Phase 2 study
By invitation Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Ophthalmic Trials Australia | Brisbane | QLD | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
1. Participants must be 18 to 40 years of age inclusive, at the time of signing the informed consent.
2. Diagnosed with progressive keratoconus in one or both eyes.
3. Minimum corneal thickness equal to or greater than 400 microns.
4. Maximum corneal keratometry of 45 D to 54 D.
5. Willing and able to comply with all clinic visits and study-related procedures and instructions.
6. Able to self-medicate or be assisted with applying study eye drops twice daily for trial duration.
7. Provide signed informed consent to participate in the study.
Exclusion Criteria:
1. Concurrent use of contact lenses, including rigid gas permeable lenses
2. Known allergy to steroids, growth factors or gellan gum
3. Presence of ocular surface inflammation at any screening visit
4. Recurrent corneal erosions
5. Significant central corneal scarring or hydrops
6. Previous corneal cross-linking
7. Previous corneal transplant
8. Previous corneal or intraocular surgeries
9. Presence of any other ocular disease of the eye (not limited to cornea) e.g. glaucoma, uveitis, uncontrolled diabetic retinopathy
10. Presence or history of ocular cancer
11. Prior ocular trauma or prior retinal detachment involving the macula
12. 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
13. Any severe comorbid condition or other issue that renders the participant unsuitable for participation in the study
14. A comorbid condition with an estimated life expectancy of ≤6 months at the time of consent
15. Systemic comorbidities that pose a significant surgical risk
16. 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)
17. Current use or anticipated use during the study of medicated lubricating eye drops or topical ophthalmic antihistamines
18. History of connective tissue disorders, collagenoses, collagen vascular diseases, autoimmune or other immune deficiency disease
19. Pregnancy or planning to become pregnant
20. 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
21. Known alcohol, drug or medication abuse within 1 year prior to consent for this study
22. 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
23. Mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
24. Participants who are employees of the Sponsor, study site or their immediate families
25. 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
26. Retinal disease, including proliferative diabetic retinopathy, retinal fibrosis, neovascular age-related macular degeneration
27. Participants in whom corneal thinning has stabilized by ophthalmologist's opinion during screening
28. Myopic degeneration with potential acuity less than 20/40 in either eye
29. Any reason for which in the opinion of the principal investigator the participant should not be enrolled into the study
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 4 February 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.