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Crosslinking Agent

Corneal Collagen Crosslinking for Keratoconus

Phase 3
Recruiting
Led By Steven A Greenstein, MD
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
Must not have
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
Clinically significant corneal scaring in the CXL treatment zone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial sought to compare the efficacy of transepithelial CXL with conventional CXL in the treatment of progressive keratoconus.

Who is the study for?
This trial is for people aged 12 or older with keratoconus or corneal ectasia, evidenced by specific patterns on a corneal map. Participants must not wear contact lenses for a week before the study and be willing to follow up. It's not for those with significant scarring in the treatment area, very thin corneas, pregnant or nursing women, certain histories of eye disease, conditions affecting epithelial healing, unstable gaze during treatment, or known drug sensitivities.
What is being tested?
The trial tests an 'Epi-on' version of Corneal Collagen Crosslinking (CXL) using Riboflavin (Vitamin B2). Unlike traditional CXL where the top layer of the cornea is removed, this method keeps it intact which may reduce infection risk and improve recovery time while treating keratoconus and post-surgery ectasia.
What are the potential side effects?
Potential side effects include discomfort in the treated eye(s), temporary visual disturbances like haziness or blurriness. There's also a reduced risk but still possible chance of infection and delayed healing due to keeping the outer layer of the cornea intact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I have been diagnosed with keratoconus or corneal ectasia after eye surgery.
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My eye condition is related to keratoconus or corneal ectasia after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of corneal disease.
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I have noticeable scarring on my cornea where I received CXL treatment.
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I have had a chemical injury or slow healing in my eye.
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I do not have any conditions that prevent me from keeping my gaze steady.
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My eyes have conditions that could lead to future problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum keratometry
Secondary study objectives
Mean keratometry

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Riboflavin drop every 2 minutesActive Control1 Intervention
Administration of one drop of Riboflavin every 2 minutes during UV exposure
Group II: Riboflavin drop every 10 minutesActive Control1 Intervention
Administration of one drop of Riboflavin every 10 minutes during UV exposure

Find a Location

Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
953 Total Patients Enrolled
9 Trials studying Keratoconus
953 Patients Enrolled for Keratoconus
Peter S Hersh, MDStudy DirectorCornea and Laser Eye Institute - Hersh Vision Group
4 Previous Clinical Trials
353 Total Patients Enrolled
4 Trials studying Keratoconus
353 Patients Enrolled for Keratoconus
Steven A Greenstein, MDPrincipal InvestigatorCornea and Laser Eye Institute - Hersh Vision Group
2 Previous Clinical Trials
180 Total Patients Enrolled
2 Trials studying Keratoconus
180 Patients Enrolled for Keratoconus

Media Library

Riboflavin (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04905108 — Phase 3
Keratoconus Research Study Groups: Riboflavin drop every 2 minutes, Riboflavin drop every 10 minutes
Keratoconus Clinical Trial 2023: Riboflavin Highlights & Side Effects. Trial Name: NCT04905108 — Phase 3
Riboflavin (Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905108 — Phase 3
Keratoconus Patient Testimony for trial: Trial Name: NCT04905108 — Phase 3
~20 spots leftby Jun 2025
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