Corneal Collagen Crosslinking for Corneal Ulcer

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

488 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The treatment works by making the cornea tougher and stronger, which helps it heal.

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 data supports the effectiveness of the treatment PXL Platinum 330 System with Riboflavin Solution for corneal ulcers?

Research shows that using ultraviolet (UV) A light and riboflavin (a type of vitamin B2) in a process called corneal collagen cross-linking (CXL) can help treat corneal ulcers, especially when other treatments haven't worked. This method has been effective in treating both severe and moderate corneal ulcers by strengthening the cornea. ^{1 2 3 4 5}

Is corneal collagen cross-linking safe for humans?

Corneal collagen cross-linking (CXL) using riboflavin and UV-A light has been studied for various eye conditions, and research generally supports its safety in humans. Studies have shown it to be safe for treating severe corneal ulcers and other conditions like keratoconus, with long-term follow-ups indicating no major safety concerns. ^{1 2 3 6 7}

How is the PXL Platinum 330 System with Riboflavin Solution treatment different from other treatments for corneal ulcers?

This treatment is unique because it uses corneal collagen cross-linking (CXL) with riboflavin and UV-A light, which strengthens the cornea by creating new bonds between collagen fibers, potentially offering a non-invasive option for corneal ulcers that do not respond to standard antimicrobial therapy. ^{1 3 5 8 9}

Research Team

Yvette Viscuso

Principal Investigator

Peschke GmbH

Bala Ambati

Principal Investigator

Pacific Clear Vision Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Corneal collagen cross-linking window absorption. [2022]

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

Ultraviolet A and riboflavin therapy as an adjunct in corneal ulcer refractory to medical treatment. [2022]

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

Can the effect of transepithelial corneal collagen cross-linking be improved by increasing the duration of topical riboflavin application? An in vivo confocal microscopy study. [2014]

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

Ultraviolet A/riboflavin collagen cross-linking for treatment of moderate bacterial corneal ulcers. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Corneal Collagen Cross-linking for Treatment of Non-healing Corneal Ulcers. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Corneal cross-linking and safety issues. [2021]

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

Corneal Cross-linking to Halt the Progression of Keratoconus and Corneal Ectasia: Seven-Year Follow-up. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Treatment Results of Corneal Collagen Cross-Linking Combined with Riboflavin and 440 Nm Blue Light for Bacterial Corneal Ulcer in Rabbits. [2018]

9. Romania pubmed.ncbi.nlm.nih.gov

Collagen crosslinking in the management of microbial keratitis. [2018]