Study of TN-001 Topical Eyedrops for Keratoconus

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