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

NCT05255016 | Unknown Phase 2 FDA Drug FDA Device

• 1 other identifier: PXL-330-02A
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 riboflavin solution) for treating refractory corneal ulcers.

  Primary Outcome Measure: 1. The composite primary endpoint outcome would be the proportion of patients in the treated group, compared to the control group, who achieve all three of the following components: * complete re-epithelialization at week 2, defined as absence of corneal fluorescein staining noted with the blue light of the slit lamp by the investigator. * no expansion of infiltrate from baseline to week 2. The size of the infiltrate will be reviewed by the investigator using the slit lamp exam and compared to baseline measures to assess expansion of the infiltrate. * a negative corneal culture at week 2 2. Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure.

  Week 2 (#+/- 2 study days).

Study Arms (2)

Standard of care + Sham CXL + Artificial Tears

SHAM COMPARATOR

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

Other: Sham CXL + Artificial Tears

Standard of care + CXL + Riboflavin 0.25% TE Solution

EXPERIMENTAL

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.

Combination Product: PXL Platinum 330 system + Riboflavin 0.25% TE Solution

Interventions

PXL Platinum 330 system + Riboflavin 0.25% TE Solution COMBINATION_PRODUCT

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).

Standard of care + CXL + Riboflavin 0.25% TE Solution

Sham CXL + Artificial Tears OTHER

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.

Standard of care + Sham CXL + Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Central corneal ulcer or hypopyon, and/or failure to improve within 24 hours of initiating conventional antibiotic eyedrops (eg, quinolone, polymyxin/trimethoprim, erythromycin, or other non-fortified antibiotics) or failure to completely re-epithelialisation within 1 week of initiating conventional antibiotic drops
• Consent to a corneal culture for bacterial keratitis (suspected keratitis is defined as a corneal epithelial defect of any size with an infiltration of the underlying stroma)
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• Minimum corneal thickness \>300 μm

You may not qualify if:

• Presence of a perforated corneal ulcer
• Presence of a corneal ulcer that has produced a descemetocele
• Presence of a corneal ulcer deeper than 50% depth or 275 μm in the cornea
• Any active ocular infection other than the central corneal ulcer or hypopyon to be treated
• Suspicion of amoebic or viral keratitis requiring treatment with topical anti- amoebic or topical antiviral ophthalmic medications
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye(s) for future complications. This may include history of or active corneal disease (eg, herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
• Uncontrolled systemic disease, especially a collagen-vascular or rheumatologic condition that could contribute to the corneal condition
• Pregnancy (or plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications

Sponsors & Collaborators

• Peschke GmbH: lead

Study Sites (12)

Colorado Eye Consultants

Littleton, Colorado, 80120, United States

RECRUITING

Gorovoy M.D Eye Specialists

Fort Myers, Florida, 33907, United States

RECRUITING

Bay Area Eye Institute

Tampa, Florida, 33613, United States

RECRUITING

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

The cornea & Laser Eye Institute-NJ

Teaneck, New Jersey, 07666, United States

RECRUITING

SightMD

Babylon, New York, 11702, United States

RECRUITING

Prisma Health Opthalmology

Columbia, South Carolina, 29203, United States

RECRUITING

Woolfson Eye

Chattanooga, Tennessee, 37421, United States

RECRUITING

Houston Eye Associates

Houston, Texas, 77008, United States

RECRUITING

San Antonio Eye Center

Lackland Air Force Base, Texas, 78236, United States

RECRUITING

Milwaukee Eye Surgeons

Milwaukee, Wisconsin, 53203, United States

RECRUITING

Valley Eye

Oshkosh, Wisconsin, 54901, United States

RECRUITING

MeSH Terms

Conditions

Keratitis; Corneal Ulcer

Interventions

Riboflavin; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Infections; Infections

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Yvette Viscuso

  Peschke GmbH

  STUDY DIRECTOR

• Bala Ambati

  Pacific Clear Vision Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Huezo-Diaz Curtis, PhD

CONTACT

0041 (0) 787 422151; Patricia.Huezo-Diaz@confinis.com

Elizabeth Hernandez, Bs

CONTACT

+1(701) 300-3702; elizabethhernandez@trialrunners.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Simple block randomization will be used to assign subjects in a 1:1 ratio to 2 treatment arms. Subjects will be randomized consecutively (not stratified by site) to ensure balance between the treatment arms at any point in the study

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 24, 2022
• Study Start: March 14, 2022
• Primary Completion: November 24, 2023
• Study Completion: February 24, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)