Corneal Collagen Cross-linking for Corneal Ectasia

(CXL Trial)

Recruiting at 11 trial locations

Overseen By Kerry Stephens, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaukos Corporation

Disqualifiers: Pregnancy, Nursing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the duration of benefits and safety of a treatment for corneal ectasia, a condition that can occur after eye surgeries like LASIK or PRK. The treatment involves corneal collagen cross-linking, which uses special eye drops and light to strengthen the cornea (the clear front part of the eye). Candidates may include those who have undergone this procedure in one or both eyes and can provide past treatment details. The study will monitor these effects for up to three years. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of this 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. It's best to discuss this with the trial team or your doctor.

What is the safety track record for corneal collagen cross-linking?

Research has shown that corneal collagen cross-linking (CXL) is generally safe for treating corneal ectasia, a condition that can develop after eye surgery to improve vision. In studies, patients who underwent CXL experienced positive results. For instance, one study found that CXL effectively managed this condition for up to five years. Another study observed a slight improvement in the cornea's shape one year after the procedure, while untreated eyes continued to worsen.

Further research confirms that CXL is both safe and effective in halting the progression of corneal ectasia, especially after surgeries like LASIK. These findings suggest that the treatment is well-tolerated with minimal risk of serious side effects. Overall, CXL appears to be a promising option for those dealing with this eye condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Corneal collagen cross-linking (CXL) is unique because it strengthens the cornea by increasing collagen bonds, offering a potential long-term solution for corneal ectasia following refractive surgery. Unlike current treatments, such as glasses, contact lenses, or corneal transplants, which mainly address symptoms or replace damaged tissue, CXL directly targets the structural weakness of the cornea. Researchers are excited about CXL because it could stabilize or even halt the progression of the condition, reducing the need for more invasive procedures in the future.

What evidence suggests that corneal collagen cross-linking is effective for corneal ectasia?

Research has shown that corneal collagen cross-linking (CXL), which participants in this trial will receive, safely and effectively stabilizes corneal ectasia. This condition occurs when the cornea, the clear front part of the eye, thins and bulges after eye surgery to correct vision. Studies have found that after CXL, patients often maintain stable vision without glasses and see better with glasses. Evidence also indicates that the cornea becomes less steep, suggesting the condition is not worsening. Overall, CXL consistently stops further damage to the cornea in affected patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Kerry Stephens

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

Provide written informed consent and sign a HIPAA form;

Willingness and ability to follow all instructions and comply with schedule for study visits;

Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Corneal collagen cross-linking treatment with Photrexa Viscous, Photrexa, and the KXL System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at Months 3, 6, 12, 24, and 36

What Are the Treatments Tested in This Trial?

Interventions

• Corneal Collagen Cross-linking

How Is the Trial Designed?

Group I: CXL Group Experimental Treatment 1 Intervention

Patients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960511/

Corneal Collagen Crosslinking for Ectasia After Refractive ... The pooled results showed a stable uncorrected visual acuity post-CXL, with a significant improvement in corrected distance visual acuity (SMD = ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1572100023002491

Results of corneal collagen cross-linking in patients with ... Corneal collagen crosslinking (CXL) is a safe and effective way of stabilizing corneal ectasia induced by LASIK (post-LASIK ectasia, PLE).

3. aaojournal.org aaojournal.org/article/S0161-6420(24)00282-3/fulltext

Safety and Efficacy of Epithelium-Off Corneal Collagen ... The study found a decrease in mean Kmax of 0.7 D from baseline at 1 year after CXL, whereas the untreated eyes continued to progress (1.3 D ...

4. vision-institute.com vision-institute.com/wp-content/uploads/U.S.-Multicenter-Clinical-Trial-of-Corneal-Collagen-Crosslinking-for-Treatment-of-Corneal-Ectasia-after-Refractive-Surgery.pdf

U.S.-Multicenter-Clinical-Trial-of-Corneal-Collagen- ... Purpose: To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of corneal ectasia after laser refractive surgery.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38525385/

Corneal Collagen Crosslinking for Ectasia After Refractive ... To assess the safety and effectiveness of corneal collagen cross-linking (CXL) for managing corneal ectasia resulting from refractive laser surgery (RSL).

6. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S370033

Visual and Topographic Outcomes of Corneal Collagen ... Our study shows that CXL is a safe and effective interventional modality for post-LASIK ectasia. It halts the ectatic pathology, reduces corneal ...