Corneal Collagen Crosslinking for Corneal Ulcer

Not currently recruiting at 11 trial locations

Overseen By Elizabeth Hernandez, Bs

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Peschke GmbH

Must not be taking: Antiviral, Anti-amoebic

Disqualifiers: Perforated ulcer, Viral keratitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment using UV-A light and a special vitamin B2 solution (PXL Platinum 330 System with Riboflavin Solution) to heal stubborn corneal ulcers, which are sores on the eye that don’t improve with regular antibiotic eye drops. The aim is to strengthen and stabilize the cornea, the clear front part of the eye. Participants will receive either the new treatment or standard care with a placebo. Individuals with a central corneal ulcer that hasn't improved with regular treatment might be suitable for this trial. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to advancing eye care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using topical anti-amoebic or antiviral eye medications, you may not be eligible to participate.

What prior data suggests that the PXL Platinum 330 System with riboflavin solution is safe for corneal collagen crosslinking?

Research has shown that the PXL Platinum 330 System with riboflavin solution is generally safe. Patients who received this treatment did not experience major side effects. The treatment uses UV-A light and a riboflavin solution to strengthen the cornea, maintaining its shape without harming vision.

Patients with conditions like corneal ulcers have reported positive outcomes, including ulcer healing. Although studies have not identified serious side effects, some patients may experience mild irritation or discomfort in the eye. This is common with light-based treatments and usually resolves quickly.

Overall, evidence suggests that the PXL Platinum 330 System is a safe option for those considering participation in a clinical trial for corneal ulcers. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for corneal ulcers?

Unlike the standard treatments for corneal ulcers, such as antibiotic eye drops or antifungal medications, the PXL Platinum 330 System with Riboflavin Solution offers a new approach by using corneal collagen crosslinking (CXL). This method involves applying a metered dose of UV-A light to the cornea, which, when combined with a riboflavin solution, strengthens the corneal tissue. Researchers are excited about this treatment because it directly targets the structural weakness in the cornea, potentially leading to more effective and faster healing of ulcers. Additionally, the use of a portable electronic device for precise delivery makes this method innovative and practical for clinical use.

What evidence suggests that the PXL Platinum 330 System with riboflavin solution is effective for treating corneal ulcers?

This trial will compare the effectiveness of corneal collagen crosslinking (CXL) with riboflavin to a sham procedure for treating corneal ulcers. Research has shown that CXL effectively treats certain eye problems, such as stabilizing the cornea's shape in people with progressive keratoconus. This treatment uses a special UV-A light and riboflavin (vitamin B2) to strengthen the cornea. Some studies suggest that CXL can also help heal stubborn corneal ulcers by strengthening the collagen fibers in the cornea, potentially speeding up healing. Participants in this trial will receive either the experimental CXL treatment with riboflavin or a sham procedure with artificial tears. ^{3 4 6 7 8}

Who Is on the Research Team?

Yvette Viscuso

Principal Investigator

Peschke GmbH

Bala Ambati

Principal Investigator

Pacific Clear Vision Institute

Are You a Good Fit for This Trial?

Adults with a central corneal ulcer or hypopyon that hasn't improved after 24 hours of standard antibiotic eye drops, or hasn't fully healed within a week. Participants must be willing to have their cornea cultured for bacteria and follow the visit schedule. Their corneas must be thicker than 300 μm. Those with perforated ulcers, other active infections, previous serious ocular conditions, uncontrolled systemic diseases, pregnancy/lactation, known drug sensitivities, or very deep ulcers are excluded.

Inclusion Criteria

I agree to have a corneal culture for an eye infection.

Willingness and ability to comply with schedule for follow-up visits

Minimum corneal thickness >300 μm

Exclusion Criteria

Pregnancy (or plan to become pregnant) or lactation during the course of the study

I have an eye infection, but it's not in the center of the cornea or causing pus in the eye.

I have a hole in my cornea due to an ulcer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive standard-of-care therapy with or without CXL treatment using the PXL Platinum 330 System

6 weeks

Day 0 (Randomization/Treatment), Day 1, Day 3, Week 1, Week 2, Week 4, Week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment, including re-epithelialization and corneal culture results

4 weeks

Follow-up at the treating physician's discretion

What Are the Treatments Tested in This Trial?

Interventions

• PXL Platinum 330 System with Riboflavin Solution

Trial Overview The trial is testing the PXL Platinum 330 System combined with riboflavin solution against a sham treatment using artificial tears. The system uses UV-A light and riboflavin to strengthen the cornea by inducing collagen crosslinking (CXL), which could help heal stubborn corneal ulcers.

How Is the Trial Designed?

Group I: Standard of care + CXL + Riboflavin 0.25% TE Solution Experimental Treatment 1 Intervention

Standard of care treatment and the experimental combination product. The PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. The riboflavin solution is an isotonic (0.9%) sodium chloride solution containing 0.25% riboflavin, 1% hydroxypropylmethylcellulose, and 0.007% benzalkonium chloride, adjusted to a pH of 7.0, and packaged in 2 mL sterile syringes for topical ophthalmic use.

Group II: Standard of care + Sham CXL + Artificial Tears Placebo Group 1 Intervention

Standard-of-care treatment and Sham CXL and administration of artificial tears.

Who Is Running the Clinical Trial?

Peschke GmbH

Lead Sponsor

Trials

2

Recruited

960+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05255107

Safety and Effectiveness of the PXL Platinum 330 System ... This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05255016/safety-and-effectiveness-of-the-pxl-platinum-330-system-with-riboflavin-solution-for-refractory-corneal-ulcers

Safety and Effectiveness of the PXL Platinum 330 System ... Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the ...

3. withpower.com withpower.com/trial/phase-2-and-3-corneal-ulcer-2-2022-48749

Corneal Collagen Crosslinking for Corneal Ulcer This trial is testing a treatment that uses a special light and vitamin B2 eye drops to help patients with hard-to-heal corneal ulcers.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/57/NCT04240457/Prot_SAP_000.pdf

Safety and Effectiveness of the PXL-Platinum 330 System ... Clinically, cross-linking has been shown to stabilize the corneal curvature in eyes with progressive keratoconus with no significant change in.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7389372/

Corneal collagen cross‐linking for bacterial infectious keratitis Safety and effectiveness of the PXL-Platinum 330 system for corneal collagen cross-linking in eyes with corneal thinning conditions. clinicaltrials.gov/ct2 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05255107?cond=%22Corneal%20Ulcer%22&intr=%22Ophthalmic%20Solutions%22&viewType=Table&rank=2

Safety and Effectiveness of the PXL Platinum 330 System ... This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal ...

7. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-the-pxl-platinum-330-system-for-corneal-collagen-cross-linking-in-eyes-w

Safety and Effectiveness of the PXL-Platinum 330 System for ... Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05255016

Safety and Effectiveness of the PXL Platinum 330 System ... The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen CXL (performed using the PXL-Platinum 330 system with ...