Corneal Cross-Linking for Keratoconus

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Glaukos Corporation

Disqualifiers: Allergy, Abnormal topography, Ocular condition

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment that uses light and vitamins to strengthen the cornea in people with keratoconus, a condition that makes the cornea thin and cone-shaped. The new treatment option aims to improve the cornea's strength and shape.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for keratoconus?

Research shows that corneal cross-linking (CXL) is effective in stopping the progression of keratoconus, a condition where the cornea (the clear front part of the eye) becomes thin and cone-shaped. Studies have demonstrated that CXL can stabilize the cornea and improve its strength, making it a reliable treatment option for this eye condition.

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Is corneal cross-linking safe for humans?

Corneal cross-linking (CXL) is generally considered safe for treating keratoconus, although rare severe complications can occur. Studies have shown it to be effective and safe in stopping the progression of keratoconus, but results can vary, especially in certain cases like very advanced keratoconus.

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How is the treatment NXL Energy 1, NXL Energy 2, NXL Energy 3 for keratoconus different from other treatments?

Corneal cross-linking (CXL) is unique because it strengthens the cornea (the clear front part of the eye) by using a special light and vitamin B2 (riboflavin) to create new bonds between collagen fibers, which helps stop the progression of keratoconus and can improve vision.

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Eligibility Criteria

This trial is for individuals with keratoconus, a condition that affects the shape of the cornea. Participants must be able to keep their gaze stable and give written consent. It's not open to those with other diseases affecting eye topography, prior eye conditions that could complicate results, or allergies to components used in the treatments.

Inclusion Criteria

Provide written informed consent

I have been diagnosed with keratoconus.

I can keep my eyes fixed on one point without moving.

Exclusion Criteria

Known allergy or sensitivity to the test articles or components

I have an eye condition that is not keratoconus.

I have an eye condition that could lead to future problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Riboflavin Ophthalmic Solution and UV-A Irradiation or a sham solution as part of the corneal cross-linking procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in visual acuity and corneal topography

12 months

Multiple visits (in-person)

Participant Groups

The study tests three different energy levels (NXL Energy 1, NXL Energy 2, NXL Energy 3) of corneal cross-linking against a sham treatment to see which is safest and most effective at stabilizing the cornea in keratoconus patients.

Group I: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1 Experimental Treatment 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group II: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

Group III: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

Group IV: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group V: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

Group VI: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

Group VII: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B Active Control 1 Intervention

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Group VIII: Placebo Group 2 / Cohort 2B Placebo Group 1 Intervention

Sham Solution with no exposure to NXL System

NXL Energy 1 is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Corneal Cross-linking for:

• Keratoconus
• Ectasia

🇺🇸 Approved in United States as Corneal Cross-linking for:

• Keratoconus
• Progressive Ectasia

🇨🇦 Approved in Canada as Corneal Cross-linking for:

• Keratoconus
• Ectasia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Glaukos Investigative Site Boston, MA

Glaukos Investigative Site Teaneck, NJ

Glaukos Investigative Site Dothan, AL

Glaukos Investigative Site Westerville, OH

Who Is Running the Clinical Trial?

Glaukos Corporation Lead Sponsor

References

1. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

The results of corneal cross-linking in the treatment of keratoconus. [2019] To estimate corneal cross-linking (CXL) in keratoconus not only as a treatment to heal and increase the corneal stability then to consider it as a refractive procedure.

2. United States pubmed.ncbi.nlm.nih.gov

Customized corneal crosslinking for treatment of progressive keratoconus: Clinical and OCT outcomes using a transepithelial approach with supplemental oxygen. [2021] To evaluate the outcomes of customized corneal crosslinking (CXL) for treatment of progressive keratoconus (KC) using a transepithelial approach with supplemental oxygen.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Patient selection for corneal collagen cross-linking: an updated review. [2020] Corneal cross-linking (CXL) is an option that in the last decade has demonstrated its efficacy and safety in halting the progression of keratoconus (KCN) and other corneal ectasias. Its indication has been extended beyond the classic definition that required evidence of KCN progression, especially in the presence of some risk factors for a possible progression (particularly the younger age). However, the results can be still somewhat variable today. There are several protocols, each with its own advantages and disadvantages. Some predictors of CXL outcome have been identified. We will review the current knowledge on patient selection for CXL, its indications, and options in special cases (such as thin corneas).

4. United States pubmed.ncbi.nlm.nih.gov

Current and future applications of corneal cross-linking. [2018] To review current concepts and future directions of corneal cross-linking (CXL) as a treatment for keratoconus, ectasia after refractive surgery and infectious keratitis.

5. United States pubmed.ncbi.nlm.nih.gov

Prospective Clinical Study of Keratoconus Progression in Patients Awaiting Corneal Cross-linking. [2021] Keratoconus progression should be treated with corneal cross-linking (CXL) in a timely manner. This study aimed to investigate patient factors associated with keratoconus progression between time of listing and at time of CXL.

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transepithelial corneal collagen crosslinking surgery versus standard corneal collagen crosslinking surgery for keratoconus: a meta-analysis of randomized controlled trials. [2022] The aim of this study was to evaluate the efficacy and safety of transepithelial corneal collagen crosslinking (transepithelial CXL) versus standard corneal collagen crosslinking (epithelium-off CXL) on keratoconus.

7. Germany pubmed.ncbi.nlm.nih.gov

Severe Complications after Corneal Collagen Cross-Linking (CXL). [2023] To present a case series of rare and severe complications after corneal collagen cross-linking (CXL) of keratoconus patients.

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Conventional Versus Accelerated Corneal Cross-linking in Pediatric Keratoconus: Two-Year Outcomes. [2021] To compare the efficacy and safety of accelerated corneal cross-linking (CXL) with conventional CXL in pediatric patients with keratoconus.

9. United States pubmed.ncbi.nlm.nih.gov

Collagen cross-linking for advanced progressive keratoconus. [2022] Collagen cross-linking (CXL) is a safe and effective procedure to stop progression of keratoconus. However, corneas with a maxK of more than 55 to 58 diopters (D) have been suggested to have an increased failure rate. We report results of CXL for progressive keratoconus in corneas with a maxK of 55 D or more.

10. United States pubmed.ncbi.nlm.nih.gov

Combined photorefractive keratectomy and corneal collagen cross-linking for treatment of keratoconus: a 2-year follow-up study. [2022] Corneal collagen cross-linking (CXL) is considered an effective procedure for slowing down or eliminating the progression of keratoconus. New techniques, in combination with CXL, have been proposed to stop the evolution of keratoconus and improve the visual function.

11. England pubmed.ncbi.nlm.nih.gov

Independent-effect comparison of five crosslinking procedures for Progressive Keratoconus based on Keratometry and the ABCD Grading System using Generalized Estimating Equations (GEE). [2023] Corneal collagen crosslinking (CXL) is an effective treatment for progressive keratoconus. Multiple CXL modalities are clinically available. The present study compared the 1 year outcomes of five types of CXL procedures for progressive keratoconus in a Chinese population using generalized estimating equations (GEE).