Recruiting
Phase 2
Phase 3

PXL Platinum 330 with Riboflavin

Sponsor:

Peschke GmbH

Code:

NCT05255107

Conditions

Keratitis

Corneal Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution

Standard of Care Therapy + Sham CXL + Artificial Tears

Study Details

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 previously untreated 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 (Riboflavin 0.23% PESCHKE-L 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 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 ophthalmic solution 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

Study ID

NCT05255107

Start date

Mar 14, 2022

Status verified date

Jul, 2022

Completion date

Feb 24, 2024

Anticipated

Primary completion date

Nov 24, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects who have one or both eyes that meet the following criteria will be considered candidates for this study:

1. 18 years of age or older
2. Ulcers that have not been treated with ophthalmic antibiotic eyedrops (eg, quinolone, polymyxin/trimethoprim, erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days
3. Consent to a corneal culture for suspected bacterial keratitis (defined as a corneal epithelial defect of any size with an infiltration of the underlying stroma)
4. Signed written informed consent
5. Willingness and ability to comply with schedule for follow-up visits
6. Minimum corneal thickness >300 μm

Exclusion Criteria:

  • All subjects meeting any of the following criteria will be excluded from this study:

1. Presence of a perforated corneal ulcer
2. Presence of a corneal ulcer that had produced a descemetocele
3. Presence of a corneal ulcer deeper than 50% depth or 275 μm in the cornea
4. Any active ocular infection other than the corneal ulcer to be treated
5. Suspicion of amoebic or viral keratitis requiring treatment with topical anti-amoebic or topical antiviral ophthalmic medications
6. 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.)
7. Uncontrolled systemic disease, especially a collagen-vascular or rheumatologic condition that could be contributing to the corneal condition
8. Pregnancy (or plan to become pregnant) or lactation during the course of the study
9. A known sensitivity to study medications
10. Presence of nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests

Study Design

Enrollment

468 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Standard of Care Therapy + Sham CXL + Artificial Tears

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

experimental: Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution

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. PESCHKE-L Solution is a riboflavin 5'-phosphate 0.23% ophthalmic solution that functions as a photosensitizer and is indicated for use with the PXL Platinum 330 Illumination System. Designed to be used when there is epithelial disruption as can occur with a corneal ulcer or wound. It does not contain benzalkonium chloride. It is intended to achieve rapid absorption.

Interventions

Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution

Standard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the experimental arm, riboflavin will be administered (1 drop every 2 min for 40 min with PESCHKE-L solution \[0.23%\], or longer as needed to assure adequate corneal penetration). Then the eye will be aligned under the PXL Platinum 330 light (the treatment plane will be at the correct working distance from the PXL Platinum 330 beam aperture when the border of the projected beam is in sharp focus). 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 Therapy + Sham CXL + Artificial Tears

Standard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the Sham comparator 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.

Primary outcome measure

  • To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers [ Time Frame: Week 2 (#+/- 2 study days). ]

Central Contacts and Locations

Central contacts

Patricia Huezo-Diaz Curtis, PhD

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

Elizabeth Hernandez, Bs

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

Locations

Colorado Eye Consultants

Recruiting

Littleton, Colorado, United States, 80120

Contacts

Lance Forstot, MD

SL4STOT@aol.com

Shivam Patel

(303) 730-0404

Gorovoy M.D Eye Specialists

Recruiting

Fort Myers, Florida, United States, 33907

Contacts

Mark Gorovoy, MD

mgorovoy@gorovoyeye.com

Carrie Soto

(239) 939-1444

Bay Area Eye Institute

Recruiting

Tampa, Florida, United States, 33613

Contacts

Craig Berger, MD

craigbergermd@gmail.com

Lisa Oliveri

(813) 265-6940

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Francis Price, MD

francisprice@pricevisiongroup.net

Marianne Price

marianneprice@cornea.org

The cornea & Laser Eye Institute-NJ

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

Peter Hersh, MD

phersh@vision-institute.com

BethAnn Furlong-Hibbert

(201) 692-9434bfurlong-hibbert@vision-institute.com

SightMD

Recruiting

Babylon, New York, United States, 11702

Contacts

Eric Rosenberg, MD

ericr29@gmail.com

Kathleen LeMier

(631)957-3355

Prisma Health Opthalmology

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Shawn Iverson, MD

Shawn.Iverson2@prismahealth.org

Woolfson Eye

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Jonathan Woolfson, MD

jwoolfson@woolfsoneye.com

Deborah Alexander-Davis

dadavis@woolfsoneye.com

Houston Eye Associates

Recruiting

Houston, Texas, United States, 77008

Contacts

Marcel Belloso

(832) 553-7100

San Antonio Eye Center

Recruiting

Lackland Air Force Base, Texas, United States, 78236

Contacts

Vasudha Panday, MD

vasudhapanday@hotmail.com

Milwaukee Eye Surgeons

Recruiting

Milwaukee, Wisconsin, United States, 53203

Contacts

Kenneth Weinlander

kweinlander@milwaukeeeyesurgeons.com

Cherry Marquez

(414) 377-5550

Valley Eye

Recruiting

Oshkosh, Wisconsin, United States, 54901

Contacts

Michael Vrabec, MD

michael.vrabec@thedacare.org

Cherie Mader

(920) 749-4064cherie.mader@thedacare.org

More Information

Sponsor

Peschke GmbH

Last update posted

Oct 28, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Peschke GmbH on 2022-10-28.