KeratoconusPhase 3NCT07124910
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
A Phase 3 study testing Epi-ON corneal cross-linking in people with Keratoconus and Ectasia of Cornea, run by Woolfson Eye Institute at 12 sites in United States.
Trial summary
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Keratoconus, Ectasia of Cornea, Pellucid Marginal Corneal Degeneration
- What is being tested?
- Epi-ON corneal cross-linking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study:
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus based on topography, tomography, and slit lamp examination.
- Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent.
- Be willing and able to follow all instructions and comply with the schedule for follow-up visits.
- If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment.
Who cannot join
- Subjects in whom the subject or study eye meets one or more of the following criteria will be excluded from the randomized cohort of the study:
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness < 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
- History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
Show all 14Show fewer
- Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking procedure.
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
- If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study.
- Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
- Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
- Inability to return for required postoperative examinations.
- Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Woolfson Eye Institute
Asheville, North Carolina, 28803
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Atlanta, Georgia, 30328
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Atlanta, Georgia, 30349
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Canton, Georgia, 30114
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Chattanooga, Tennessee, 37421
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Cumming, Georgia, 30041
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Douglasville, Georgia, 30134
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Johnson City, Tennessee, 37615
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Knoxville, Tennessee, 37922
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Lawrenceville, Georgia, 30043
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Marietta, Georgia, 30066
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
- Recruiting
Woolfson Eye Institute
Snellville, Georgia, 30078
LuAnn Bryant, 770-804-1684 ext. 155, lbryant@woolfsoneye.com
About this study
Official title: Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure Versus a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred.
CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus.
Read more
The main question it aims to answer is:
- Does CXL help prevent or slow the progression of someone's corneal condition and vision loss?
Participants will:
- Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given.
Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light).
- There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.
- Conditions
- Keratoconus, Ectasia of Cornea, Pellucid Marginal Corneal Degeneration, Forme Fruste Keratoconus (FFK)
- Being tested
- Epi-ON corneal cross-linking
- Keywords
- crosslinking, corneal, Epi-ON, UVA
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi-ON corneal cross-linkingCombination product
Corneal cross-linking involves the following steps:
- applying riboflavin (Vitamin B2 eye drops) to the eye, then
- exposing the eye to ultraviolet (UV-A) light
| Study group | Role | What they receive |
|---|---|---|
| UVA 18 minute | Experimental | Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes Receives: Combination Product: Epi-ON corneal cross-linking |
| UVA 24 minute | Experimental | Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes Receives: Combination Product: Epi-ON corneal cross-linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes and CDVA.
The change in keratometry (Kmax) and corrected visual acuity from baseline will be evaluated at 6 months for all eyes treated. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests. The change in Kmax and corrected visual acuity from baseline will be evaluated at 6 months.
Measured: From enrollment to the end of treatment at 6 months.
Secondary outcomes (3)
Change in UCVA compared to the baseline examination will be used as a Secondary outcome measurement.
Change in UCVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Measured: 6 months
At the Sponsor-Investigator's discretion, the change in HOA from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Measured: 6 months
At the Sponsor-Investigator's discretion, the change in coma from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Aug 2025
- Primary completionNov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- None (open label)
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woolfson Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124910
- Sponsor's protocol ID
- WEI-CXL-003
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure Versus a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
- ClinicalTrials.gov ID
- NCT07124910
- Acronym / sponsor ID
- WEI-CXL-003
- Conditions
- Keratoconus, Ectasia of Cornea, Pellucid Marginal Corneal Degeneration, Forme Fruste Keratoconus (FFK)
- Keywords
- crosslinking, corneal, Epi-ON, UVA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- Woolfson Eye InstituteUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Aug 2025 (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.
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred.
CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus.
The main question it aims to answer is:
- Does CXL help prevent or slow the progression of someone's corneal condition and vision loss?
Participants will:
- Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given.
Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light).
- There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVA 18 minute | Experimental | Combination Product: Epi-ON corneal cross-linkingSubjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes |
| UVA 24 minute | Experimental | Combination Product: Epi-ON corneal cross-linkingSubjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study:
- Be at least 8 years of age or older, male or female, of any race.
- Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus based on topography, tomography, and slit lamp examination.
- Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent.
- Be willing and able to follow all instructions and comply with the schedule for follow-up visits.
Key exclusion criteria (14 listed)
- Subjects in whom the subject or study eye meets one or more of the following criteria will be excluded from the randomized cohort of the study:
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness < 300 (measured by Pentacam and Ultrasound) at the screening exam.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
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 |
|---|---|---|
| Epi-ON corneal cross-linkingCorneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light | Combination product | UVA 18 minute, UVA 24 minute |
Primary outcome
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes and CDVA.
Time frame: From enrollment to the end of treatment at 6 months.
The change in keratometry (Kmax) and corrected visual acuity from baseline will be evaluated at 6 months for all eyes treated. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests. The change in Kmax and corrected visual acuity from baseline will be evaluated at 6 months.
3 secondary outcomes
Change in UCVA compared to the baseline examination will be used as a Secondary outcome measurement.
Time frame: 6 months
At the Sponsor-Investigator's discretion, the change in HOA from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Time frame: 6 months
At the Sponsor-Investigator's discretion, the change in coma from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Epi-ON corneal cross-linking in people with Keratoconus and Ectasia of Cornea, run by Woolfson Eye Institute 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Feb 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LuAnn Bryant (770-804-1684 ext. 155, lbryant@woolfsoneye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes and CDVA. (time frame: From enrollment to the end of treatment at 6 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 2 Feb 2026.