Corneal Collagen Crosslinking for Corneal Ulcer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen ByBala Ambati

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Peschke GmbH

No Placebo Group

Prior Safety Data

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.

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.

Exclusion Criteria

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

I have a deep corneal ulcer.

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

I do not have an uncontrolled systemic disease affecting my cornea.

I have a severe ulcer in my eye.

I am suspected to have an eye infection needing special eye drops.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard of care + CXL + Riboflavin 0.25% TE SolutionExperimental Treatment1 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 TearsPlacebo Group1 Intervention

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