- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255107
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
Study Overview
Status
Conditions
Detailed Description
This is a prospective, 2-arm parallel-group, single-masked, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with previously untreated corneal ulcers. Subjects with documented infectious corneal ulcers that have not been treated (treatment na ve) will be evaluated initially for suitability as candidates 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, both including standard of care (SOC) treatment:
- SOC: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion
- CXL + SOC: Moxifloxacin 0.5% eyedrop 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), and Week 4 ( 3 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Colorado
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Littleton, Colorado, United States, 80120
- Recruiting
- Colorado Eye Consultants
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Contact:
- Lance Forstot, MD
- Email: SL4STOT@aol.com
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Contact:
- Shivam Patel
- Phone Number: (303) 730-0404
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Florida
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Fort Myers, Florida, United States, 33907
- Recruiting
- Gorovoy M.D Eye Specialists
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Contact:
- Mark Gorovoy, MD
- Email: mgorovoy@gorovoyeye.com
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Contact:
- Carrie Soto
- Phone Number: (239) 939-1444
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Tampa, Florida, United States, 33613
- Recruiting
- Bay Area Eye Institute
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Contact:
- Craig Berger, MD
- Email: craigbergermd@gmail.com
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Contact:
- Lisa Oliveri
- Phone Number: (813) 265-6940
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Indiana
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Indianapolis, Indiana, United States, 46260
- Recruiting
- Price Vision Group
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Contact:
- Francis Price, MD
- Email: francisprice@pricevisiongroup.net
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Contact:
- Marianne Price
- Email: marianneprice@cornea.org
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New Jersey
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Teaneck, New Jersey, United States, 07666
- Recruiting
- The cornea & Laser Eye Institute-NJ
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Contact:
- Peter Hersh, MD
- Email: phersh@vision-institute.com
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New York
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Babylon, New York, United States, 11702
- Recruiting
- SightMD
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Contact:
- Eric Rosenberg, MD
- Email: ericr29@gmail.com
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Contact:
- Kathleen LeMier
- Phone Number: (631)957-3355
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South Carolina
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Columbia, South Carolina, United States, 29203
- Recruiting
- Prisma Health Opthalmology
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Contact:
- Shawn Iverson, MD
- Email: Shawn.Iverson2@prismahealth.org
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- Recruiting
- Woolfson Eye
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Contact:
- Jonathan Woolfson, MD
- Email: jwoolfson@woolfsoneye.com
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Contact:
- Deborah Alexander-Davis
- Email: dadavis@woolfsoneye.com
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Texas
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Houston, Texas, United States, 77008
- Recruiting
- Houston Eye Associates
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Contact:
- Marcel Belloso
- Phone Number: (832) 553-7100
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Lackland Air Force Base, Texas, United States, 78236
- Recruiting
- San Antonio Eye Center
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Contact:
- Vasudha Panday, MD
- Email: vasudhapanday@hotmail.com
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Wisconsin
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Milwaukee, Wisconsin, United States, 53203
- Recruiting
- Milwaukee Eye Surgeons
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Contact:
- Kenneth Weinlander
- Email: kweinlander@milwaukeeeyesurgeons.com
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Contact:
- Cherry Marquez
- Phone Number: (414) 377-5550
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Oshkosh, Wisconsin, United States, 54901
- Recruiting
- Valley Eye
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Contact:
- Michael Vrabec, MD
- Email: michael.vrabec@thedacare.org
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Contact:
- Cherie Mader
- Phone Number: (920) 749-4064
- Email: cherie.mader@thedacare.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects who have one or both eyes that meet the following criteria will be considered candidates for this study:
- 18 years of age or older
- 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
- 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)
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Minimum corneal thickness >300 μm
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
- Presence of a perforated corneal ulcer
- Presence of a corneal ulcer that had 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 corneal ulcer 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 be contributing to the corneal condition
- Pregnancy (or plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Presence of nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Standard of Care Therapy + Sham CXL + Artificial Tears
Standard-of-care treatment and Sham CXL and administration of 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.
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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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers
Time Frame: Week 2 (#+/- 2 study days).
|
Primary Outcome Measure:
|
Week 2 (#+/- 2 study days).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Eye Diseases
- Corneal Diseases
- Eye Infections
- Ulcer
- Keratitis
- Corneal Ulcer
- Physiological Effects of Drugs
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Vitamin B Complex
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Riboflavin
- Lubricant Eye Drops
Other Study ID Numbers
- PXL-330-02B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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