Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers

Summary

This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of refractory corneal ulcers. The PXL Platinum 330 System is a combination product consisting of an ultraviolet-A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke Riboflavin 0.25% Transepithelial Solution) administered in conjunction with the UV-A light as a photosensitizer.

The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma. Corneal collagen CXL is performed by pretreating the cornea with riboflavin 0.25% ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer. The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min. Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin (0.25%) has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils. Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea. Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.

Conditions

• Keratitis
• Corneal Ulcer

Interventions

COMBINATION_PRODUCT

PXL Platinum 330 system + Riboflavin 0.25% TE Solution

Standard-of-care therapy (antifungal drops or fortified antibiotics and empiric antibiotic drops). In addition CXL + Riboflavin 0.25% TE solution. After topical anesthesia, the surgeon or trained designee will apply topical riboflavin (1 drop every 2 min for 40 min with PESCHKE TE solution \[0.25%\], or longer as needed to assure adequate corneal penetration). At the end of this pre-treatment period, the eye will be examined at the slit lamp with the blue filter for the presence of riboflavin throughout the stroma. When sufficient corneal riboflavin penetration is confirmed, the eye will be aligned under the PXL Platinum 330 light. The correct aperture setting (3 to 12 mm) will be selected for the size of the eye and area needing to be treated (2 mm larger than the maximal ulcer diameter), and the eye will be irradiated at 18 mW/cm2, with pulsed mode (5 seconds on, 5 seconds off) for 10 min, during which time instillation of riboflavin will continue (1 drop every 2 min).

OTHER

Sham CXL + Artificial Tears

Standard-of-care therapy (antifungal drops or fortified antibiotics and empiric antibiotic drops). In addition, for subjects in the sham group, artificial tears (1 drop every 2 min for 40 min) will be administered. after instillation of artificial tears, the eye will be aligned under the PXL Platinum 330 light. The instrument will be kept off and the subject will be kept under the device for 10 min during which time instillation of artificial tears will be performed (1 drop every 2 min) to maintain corneal hydration. The operator will keep track of sham exposure time independently to confirm the actual duration.

Sponsors & Collaborators

• Peschke GmbH

  lead INDUSTRY

Principal Investigators

• Yvette Viscuso · Peschke GmbH

• Bala Ambati · Pacific Clear Vision Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-14

Primary Completion

2023-11-24

Completion

2024-02-24

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations