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

Epion Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Keratoconus

Treatments: Combination Product: Placebo and sham treatment; Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06100952

CXL-006-B

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 8 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Active Treatment

Experimental group

Description:

Epithelium-on corneal cross-linking

Treatment:

Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment

Control Treatment

Placebo Comparator group

Description:

Placebo and sham for epithelium-on corneal cross-linking

Treatment:

Combination Product: Placebo and sham treatment