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The trial is taking place at:
V

VRF Eye Specialty Group | Memphis, TN

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

E

Epion Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Keratoconus

Treatments

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

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

Trial contacts and locations

13

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Central trial contact

Michael Belin, MD

Data sourced from clinicaltrials.gov

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