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Photosensitizer

Corneal Collagen Crosslinking for Keratoconus

Phase 3
Recruiting
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
18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
Axial topography consistent with keratoconus or post-surgical corneal ectasia
Must not have
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
Clinically significant scarring in the CXL treatment zone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial found that the accelerated crosslinking method was effective in reducing the progression of keratoconus.

Who is the study for?
Adults diagnosed with keratoconus or corneal ectasia following refractive surgery can join. They must have specific corneal steepening, be willing to follow the visit schedule, and not wear contact lenses for a week before screening. Pregnant women, those planning pregnancy, lactating individuals, or people with certain eye conditions or sensitivities are excluded.
What is being tested?
The trial is testing an accelerated method of strengthening the cornea using riboflavin ophthalmic solution and UV-A light (either pulsed or continuous). The goal is to see if this speeds up oxygenation and improves treatment outcomes for patients with keratoconus or ectasia.
What are the potential side effects?
Potential side effects may include discomfort during UV exposure, temporary vision changes, inflammation of the eye, possible scarring in the treatment zone, and delayed healing of the cornea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with a diagnosis of keratoconus or corneal ectasia.
Select...
My eye condition is related to keratoconus or corneal ectasia after surgery.
Select...
I am 18 or older with a diagnosis of keratoconus or corneal ectasia.
Select...
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:
Select...
I have had eye conditions that could cause future issues, excluding vision correction needs.
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I have noticeable scarring in the treated eye area.
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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 like nystagmus that would prevent me from keeping my gaze steady during treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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.
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: Continuous UVAActive Control1 Intervention
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time
Group II: Pulsed UVAActive Control1 Intervention
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time

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

Media Library

Riboflavin Ophthalmic Solution (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05027295 — Phase 3
Keratoconus Research Study Groups: Continuous UVA, Pulsed UVA
Keratoconus Clinical Trial 2023: Riboflavin Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT05027295 — Phase 3
Riboflavin Ophthalmic Solution (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027295 — Phase 3
~22 spots leftby Jul 2025
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