Clinical trial

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

Name

PXL-330-02A

Description

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.

Trial arms

Trial start

2022-03-14

Estimated PCD

2023-11-24

Trial end

2024-02-24

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

Standard of care + CXL + Riboflavin 0.25% TE Solution

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.

Arms:

Standard of care + Sham CXL + Artificial Tears

Size

488

Primary endpoint

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.

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 488, 'type': 'ESTIMATED'}}

Updated at

2022-10-28

1 organization

1 product

2 indications

Organization

Product

Indication

Indication