225 Participants Needed

Corneal Crosslinking for Keratoconus

Recruiting at 10 trial locations
LB
Overseen ByLuAnn Bryant
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Clinical Research Consultants, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called corneal crosslinking (CXL) to determine if it can halt the progression of eye conditions like keratoconus, which thins and misshapes the cornea, causing blurry vision. CXL involves applying vitamin B2 eye drops and using UV light to strengthen the cornea. The trial is open to individuals 8 years or older with Down syndrome and a diagnosed corneal condition, such as keratoconus. Participants must attend several office visits for eye tests over six months. As a Phase 3 trial, this represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to remove contact lenses for a certain period before exams.

What prior data suggests that corneal crosslinking is safe for treating keratoconus in individuals with Down syndrome?

Research has shown that Epi-ON corneal collagen crosslinking (CXL) is generally safe and well-tolerated. In studies, this treatment caused fewer side effects compared to other methods. Epi-ON CXL helps halt keratoconus, a condition where the cornea becomes thin and misshapen. By keeping the eye's surface intact during the procedure, the risk of infection decreases, and recovery speeds up, enhancing patient comfort. Overall, the treatment is considered safe, making it a promising option for those considering it.12345

Why do researchers think this study treatment might be promising?

Epi-ON Corneal Collagen Crosslinking is unique because it offers a gentler approach to treating keratoconus that doesn't require removing the eye's outer layer, unlike the standard Epi-OFF procedure. This non-invasive method reduces discomfort and speeds up recovery time, making it more convenient for patients. Researchers are excited because it maintains the integrity of the corneal epithelium, potentially lowering the risk of infection and other complications associated with traditional crosslinking treatments.

What evidence suggests that corneal crosslinking might be an effective treatment for keratoconus?

Research has shown that Epi-On Corneal Collagen Crosslinking (CXL) effectively halts the progression of keratoconus. Keratoconus causes the cornea, the clear front part of the eye, to become thin and misshapen. Studies have found that this treatment can improve vision and flatten the cornea, reducing blurred vision. In previous research, none of the patients who underwent Epi-On CXL experienced further corneal issues. This suggests that Epi-On CXL is both safe and effective in preventing the condition from worsening. While other treatments exist, Epi-On CXL stands out because it works without removing the outer layer of the cornea, making it safer and more comfortable for patients.12367

Are You a Good Fit for This Trial?

This trial is for individuals aged 8 or older with Down syndrome and corneal diseases like keratoconus. They must be able to follow instructions and attend follow-up visits. Consent is required, with assent for those under 14 or consent by a legal representative if needed.

Inclusion Criteria

I am at least 8 years old.
I have passed a test that says I am a good candidate for CXL treatment.
I have a condition like Down syndrome that makes it hard for me to follow instructions or do certain tests.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Epi-ON corneal cross-linking (CXL) treatment, involving riboflavin (Vitamin B2) eye drops and UV-A light exposure for 20 minutes

6 months
7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of vision improvements

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Epi-ON Corneal Collagen Crosslinking

Trial Overview

The study tests Epi-ON corneal cross-linking (CXL), which involves applying riboflavin drops to the eye followed by UVA light exposure, aiming to strengthen the cornea and halt disease progression in participants over a series of seven office visits in six months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Enrolled and treated subject armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Clinical Research Consultants, Inc.

Lead Sponsor

Trials
7
Recruited
1,400+

Woolfson Eye Institute

Lead Sponsor

Citations

Outcomes of Epi-On Collagen Cross-Linkage Procedure ...

Epi-on CXL is an effective treatment for halting the progression of keratoconus. Our results showed significant improvement in visual acuity and K-max readings.

Efficacy and Safety of Epi-On vs Epi-Off Corneal Cross- ...

This review compares two CXL methods, epithelium-on (epi-on) and epithelium-off (epi-off), to assess their safety and effectiveness for managing corneal ...

Long-Term Outcomes in Crosslinking Therapy for Patients ...

Keratoconus progression was observed in 11 (4.1%) patients who underwent epi-off CXL. None of the patients who underwent epi-On CXL developed corneal turbidity, ...

Epithelial-On (EPI-On) Corneal-Collagen Cross-Linking ...

This result tells us that standard Epi-Off CXL is more effective at flattening the anterior corneal surface than AXL in the long run.

Safety and Efficacy of Epithelium-Off Corneal Collagen ...

Epithelium-off CXL is effective in reducing the progression of KCN and post–laser refractive surgery ectasia in most treated patients with an ...

What's Next for Corneal Cross-Linking

By preserving the epithelium, epi-on CXL offers improved patient comfort, reduced risk of infection and quicker recovery. The improved safety ...

Epi-off CXL outperforms accelerated epi-on CXL in ...

Outcomes. Both groups experienced mean improvement in BCVA at 5 years, but 3 eyes that progressed in the epi-on CXL group lost lines of BCVA ...