A Phase 3 interventional study of Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment and Placebo and sham treatment in Keratoconus, sponsored by Epion Therapeutics. Completed at 12 sites in United States. Open to participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Epion Therapeutics · Phase 3, Interventional, and Treatment
A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 398 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Epion Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epithelium-on corneal cross-linking
Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
Placebo and sham for epithelium-on corneal cross-linking
Combination Product: Placebo and sham treatment
Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source
Drug: placebo ophthalmic solution Device: UV-3000 light source
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
BSCDVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The score ranges from 0 to 100, with a higher score representing better visual functioning.
Time frame: Baseline to 12 months
Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)
The score on the NEI-VFQ-25 ranges from 0 to 100, with a higher score indicating greater functioning.
Time frame: Baseline to 12 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Epion Therapeutics