Clinical trial
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
Name
PXL-330-02B
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 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.
Trial arms
Trial start
2022-03-14
Estimated PCD
2023-11-24
Trial end
2024-02-24
Status
Recruiting
Phase
Early phase I
Treatment
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).
Arms:
Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution
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.
Arms:
Standard of Care Therapy + Sham CXL + Artificial Tears
Size
468
Primary endpoint
To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers
Week 2 (#+/- 2 study days).
Eligibility criteria
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
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': 468, 'type': 'ESTIMATED'}}
Updated at
2022-10-28
1 organization
Organization
Peschke