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Collagen Crosslinking Agent

Corneal Collagen Crosslinking for Keratoconus (CXL Trial)

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
Axial topography consistent with keratoconus or post-surgical corneal ectasia
12 years of age or older
Must not have
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if corneal crosslinking using two different riboflavin formulations can improve keratoconus or corneal ectasia.

Who is the study for?
This trial is for people aged 12 or older with keratoconus or corneal ectasia, who can remove their contact lenses a week before testing and attend follow-up visits. Pregnant individuals, those with thin corneas, previous eye conditions that may cause complications, or sensitivity to study medications cannot participate.
What is being tested?
The trial tests the safety and effectiveness of two isotonic riboflavin solutions in reducing corneal curvature through corneal collagen crosslinking (CXL) in patients with keratoconus or post-surgical corneal ectasia.
What are the potential side effects?
Potential side effects are not detailed here but generally could include discomfort at the treatment site, changes in vision, eye irritation or inflammation. Specific risks will be discussed prior to consent.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any conditions like nystagmus that would prevent me from keeping my gaze steady during treatments.
Select...
I have had a chemical injury or slow healing in my eye.
Select...
I have had eye conditions or diseases that could complicate future treatments.

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
Visual acuity

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: CXL using Riboflavin/Dextran solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran
Group II: CXL usinng Riboflavin/Methylcellulose solutionActive Control1 Intervention
Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

Find a Location

Who is running the clinical trial?

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

Media Library

Riboflavin (Collagen Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04897503 — Phase 3
Keratoconus Research Study Groups: CXL using Riboflavin/Dextran solution, CXL usinng Riboflavin/Methylcellulose solution
Keratoconus Clinical Trial 2023: Riboflavin Highlights & Side Effects. Trial Name: NCT04897503 — Phase 3
Riboflavin (Collagen Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897503 — Phase 3
Keratoconus Patient Testimony for trial: Trial Name: NCT04897503 — Phase 3
~21 spots leftby Jun 2025
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