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

Primary Purpose

Keratitis, Corneal Ulcer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PXL Platinum 330 system + Riboflavin 0.25% TE Solution
Sham CXL + Artificial Tears
Sponsored by
Peschke GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age or older
  2. 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
  3. 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)
  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:

  1. Presence of a perforated corneal ulcer
  2. Presence of a corneal ulcer that has 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 central corneal ulcer or hypopyon 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 contribute 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

Sites / Locations

  • Colorado Eye ConsultantsRecruiting
  • Gorovoy M.D Eye SpecialistsRecruiting
  • Bay Area Eye InstituteRecruiting
  • Price Vision GroupRecruiting
  • The cornea & Laser Eye Institute-NJRecruiting
  • SightMDRecruiting
  • Prisma Health OpthalmologyRecruiting
  • Woolfson EyeRecruiting
  • Houston Eye AssociatesRecruiting
  • San Antonio Eye CenterRecruiting
  • Milwaukee Eye SurgeonsRecruiting
  • Valley EyeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Standard of care + Sham CXL + Artificial Tears

Standard of care + CXL + Riboflavin 0.25% TE Solution

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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: 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 Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2022
Last Updated
October 26, 2022
Sponsor
Peschke GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05255016
Brief Title
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers
Official Title
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
February 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peschke GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, 2-arm parallel-group, single-blind, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with refractory corneal ulcers. Subjects with a history of non-resolving infective corneal ulcers will be evaluated initially for suitability as a candidate for CXL. Subjects who are candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required study procedures that are not part of the investigator's routine examination. After completing screening procedures, the diagnosis for each eligible eye will be confirmed. Subjects will be randomized to 1 of 2 groups: Group 1: Standard-of-care therapy (anti fungal drops if there is clinical suspicion for fungus, fortified antibiotics if corneal culture is positive for a specific organism sensitive to a fortified antibiotic, and empiric antibiotic drops based on community prevalence if corneal culture is negative and there is no clinical suspicion for fungus) Group 2: Standard-of-care therapy + CXL Eyes undergoing CXL will have topical anesthetic administered and then have topical riboflavin instilled onto the cornea every 2 min (or longer as needed to assure adequate corneal penetration), after which the cornea will be exposed to UV-A pulsed light 18 mW/cm2 for 10 min. Riboflavin instillation will continue every 2 min during CXL. The CXL procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UV-A light source and riboflavin solution). All use of the PXL Platinum 330 System will be in accordance with this protocol and the general instructions provided by the manufacturer (PESCHKE) in the PXL Platinum 330 Illumination System Operator's Manual. All subjects will be evaluated at Screening/Baseline, Day 0 (Randomization/Treatment), Day 1, Day 3 ( +/- 1 day), Week 1 ( +/- 2 days), Week 2 ( +/- 2 days), Week 4 ( +/- 3 days), and Week 6 ( +/- 4 days) after treatment. Efficacy monitoring throughout the study will include observations at appropriate times for re-epithelialization, size of infection, and corneal culture results. Safety monitoring throughout the study will include observations at appropriate times for pain, IOP, BSCVA, corneal scar size, AEs, clinically significant findings on ophthalmic examination, dilated fundus examination, and slit lamp examination. After treatment, subjects will be followed at the treating physician's discretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Corneal Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
488 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care + Sham CXL + Artificial Tears
Arm Type
Sham Comparator
Arm Description
Standard-of-care treatment and Sham CXL and administration of artificial tears.
Arm Title
Standard of care + CXL + Riboflavin 0.25% TE Solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
PXL Platinum 330 system + Riboflavin 0.25% TE Solution
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Sham CXL + Artificial Tears
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Primary Outcome Measure: 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 Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure.
Time Frame
Week 2 (#+/- 2 study days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Huezo-Diaz Curtis, PhD
Phone
0041 (0) 787 422151
Email
Patricia.Huezo-Diaz@confinis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hernandez, Bs
Phone
+1(701) 300-3702
Email
elizabethhernandez@trialrunners.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette Viscuso
Organizational Affiliation
Peschke GmbH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bala Ambati
Organizational Affiliation
Pacific Clear Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Eye Consultants
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Forstot, MD
Facility Name
Gorovoy M.D Eye Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Gorovoy, MD
Facility Name
Bay Area Eye Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Berger, MD
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Price, MD
Facility Name
The cornea & Laser Eye Institute-NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hersh, MD
Facility Name
SightMD
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Rosenberg, MD
Facility Name
Prisma Health Opthalmology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Iverson, MD
Facility Name
Woolfson Eye
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Woolfson, MD
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Goosey, MD
Facility Name
San Antonio Eye Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasudha Panday, MD
Facility Name
Milwaukee Eye Surgeons
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Weinlander
Facility Name
Valley Eye
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Vrabec, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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