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Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus

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 (APRICITY-B)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06100952
Acronym
Apricity-B
Enrollment
398
Registered
2023-10-25
Start date
2023-11-01
Completion date
2026-03-17
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Brief summary

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

Interventions

COMBINATION_PRODUCTRiboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source

COMBINATION_PRODUCTPlacebo and sham treatment

Drug: placebo ophthalmic solution Device: UV-3000 light source

Sponsors

Epion Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of keratoconus

Exclusion criteria

* Minimal corneal thickness \< 350 microns * Non-keratoconic ectatic disease * Contraindications or hypersensitivities to any required study medications * Pregnancy or breastfeeding * Certain concomitant ocular conditions

Design outcomes

Primary

MeasureTime frameDescription
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)Baseline to 12 monthsBSCDVA 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.

Secondary

MeasureTime frameDescription
Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)Baseline to 12 monthsThe score on the NEI-VFQ-25 ranges from 0 to 100, with a higher score indicating greater functioning.

Countries

United States

Contacts

STUDY_DIRECTORMichael Belin, MD

Epion Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026