- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06100939
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus (Apricity-A)
January 23, 2024 updated by: Epion Therapeutics
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-A)
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
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Belin, MD
- Phone Number: 781-281-4525
- Email: support@epiontx.com
Study Locations
-
-
California
-
Rowland Heights, California, United States, 91748
- Recruiting
- Nvision Eye Centers Rowland Heights
-
Contact:
- Dagny Zhu Luong, MD
-
San Francisco, California, United States, 94115
- Recruiting
- Goodman Eye Center
-
Contact:
- Daniel Goodman, MD
-
-
Florida
-
Miami, Florida, United States, 33176
- Recruiting
- Center for Excellence in Eye Care
-
Contact:
- William Trattler, MD
-
-
Illinois
-
Hoffman Estates, Illinois, United States, 60169
- Recruiting
- Chicago Cornea Consultants
-
Contact:
- Parag Majmudar, MD
-
-
Massachusetts
-
Brookline, Massachusetts, United States, 02445
- Recruiting
- Boston Vision
-
Contact:
- Samir Melki, MD
-
-
Missouri
-
Saint Louis, Missouri, United States, 63131
- Recruiting
- Ophthalmology Associates
-
Contact:
- Gregg Berdy, MD
-
-
New York
-
East Syracuse, New York, United States, 13057
- Recruiting
- The Eye Doctors at CNY Eye Care
-
Contact:
- Matthew Weinstein, DO
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Recruiting
- Cincinnati Eye Institute
-
Contact:
- Adam Kaufman, MD
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Dean McGee Eye Institute
-
Contact:
- Kamran Riaz, MD
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Recruiting
- Devers Eye Institute
-
Contact:
- Michael Straiko, MD
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Not yet recruiting
- University of Virginia
-
Contact:
- Tara McGehee, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Treatment
Epithelium-on corneal cross-linking
|
Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source |
Placebo Comparator: Control Treatment
Placebo and sham for epithelium-on corneal cross-linking
|
Drug: placebo ophthalmic solution Device: UV-3000 light source |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
Time Frame: Baseline to 12 months
|
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.
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)
Time Frame: Baseline to 12 months
|
The score on the NEI-VFQ-25 ranges from 0 to 100, with a higher score indicating greater functioning.
|
Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael Belin, MD, Epion Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2023
Primary Completion (Estimated)
October 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 20, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Estimated)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CXL-006-A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratoconus
-
The Cleveland ClinicUniversity of MarylandEnrolling by invitationKeratoconus | Keratoconus, Unstable | Keratoconus, StableUnited States
-
Eye Hospital Pristina KosovoActive, not recruitingKeratoconus | Keratoconus of Right Eye | Keratoconus, Unstable, Right EyeKosovo
-
Tianjin Eye HospitalRecruitingScansys, Pentacam, Keratoconus, Subclinical KeratoconusChina
-
Tianjin Eye HospitalActive, not recruitingScansys, Pentacam, Corvis ST, Keratoconus, Subclinical KeratoconusChina
-
Heba Allah Nashaat MohamedAssiut UniversityRecruitingKeratoconus, CollagenEgypt
-
Kent Wellish MDNot yet recruitingKeratoconus, Unstable
-
Kasr El Aini HospitalUnknownProgressive KeratoconusEgypt
-
Centre Hospitalier Régional Metz-ThionvilleCompletedProgressive Keratoconus
-
Glaukos CorporationCompletedProgressive KeratoconusUnited States
-
Tianjin Eye HospitalCompletedKeratoconus, StableChina
Clinical Trials on Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
-
Epion TherapeuticsRecruitingKeratoconusUnited States
-
CxlusaCompleted
-
Oslo University HospitalUnknownKeratoconus | Corneal Ectasia
-
Cornea and Laser Eye InstituteActive, not recruitingKeratoconus | Corneal EctasiaUnited States
-
University of OxfordNational Institute for Health Research, United Kingdom; University of DundeeCompletedTransient HypothyroxinemiaUnited Kingdom
-
Medstar Health Research InstituteTerminated
-
Medstar Health Research InstituteTerminatedThyroid CancerUnited States
-
Creighton UniversityCompletedDental CariesUnited States
-
Mashhad University of Medical SciencesCompleted
-
Glaukos CorporationWithdrawn