KeratoconusPhase 3Apricity-BNCT06100952
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
A Phase 3 study testing Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment in people with Keratoconus, run by Epion Therapeutics at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 45 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Nov 2023to 17 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of keratoconus
Who cannot join
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Colorado
Aurora, Colorado, 80045
Dell Laser Consultants
Austin, Texas, 78746
Providence Eye and Laser Specialists
Charlotte, North Carolina, 28226
Hoopes Vision
Draper, Utah, 84020
Chicago Cornea Consultants
Highland Park, Illinois, 60035
VRF Eye Specialty Group
Memphis, Tennessee, 38120
Inland Eye Specialists
Murrieta, California, 92562
Virginia Eye Consultants
Norfolk, Virginia, 23502
Claris Vision LLC Eye Health Vision Centers - Dartmouth
North Dartmouth, Massachusetts, 02747
Truhlsen Eye Institute
Omaha, Nebraska, 68105
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
Catalina Eye Center
Tucson, Arizona, 85712
About this study
Official title: 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)
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
- Conditions
- Keratoconus
- Being tested
- Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment, Placebo and sham treatment
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin and Sodium Iodide solution and Ultraviolet-A treatmentCombination product
Drug: Ribostat riboflavin and sodium iodide ophthalmic solution
Device: UV-3000 ultraviolet A light source
Placebo and sham treatmentCombination product
Drug: placebo ophthalmic solution
Device: UV-3000 light source
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Epithelium-on corneal cross-linking Receives: Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment |
| Control Treatment | Placebo comparator | Placebo and sham for epithelium-on corneal cross-linking Receives: Combination Product: Placebo and sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (1)
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023
- Primary completion13 Feb 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Belin, MD, Study director, Epion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100952
- Sponsor's protocol ID
- CXL-006-B
- Acronym
- Apricity-B
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06100952
- Acronym / sponsor ID
- Apricity-B / CXL-006-B
- Conditions
- Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Epion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Combination Product: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatmentEpithelium-on corneal cross-linking |
| Control Treatment | Placebo comparator | Combination Product: Placebo and sham treatmentPlacebo and sham for epithelium-on corneal cross-linking |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of keratoconus
Key exclusion criteria (5 listed)
- Minimal corneal thickness < 350 microns
- Non-keratoconic ectatic disease
- Contraindications or hypersensitivities to any required study medications
- Pregnancy or breastfeeding
- Certain concomitant ocular conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin and Sodium Iodide solution and Ultraviolet-A treatmentDrug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source | Combination product | Active Treatment |
| Placebo and sham treatmentDrug: placebo ophthalmic solution Device: UV-3000 light source | Combination product | Control Treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Related trials for Keratoconus
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Belin, MD study director
Epion Therapeutics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment in people with Keratoconus, run by Epion Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.