Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

NCT04667572 | Completed Phase 1 FDA Drug

• 1 other identifier: PXL-330-CAT-2
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Conditions

Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia

Outcome Measures

Primary Outcomes (2)

• K-Max

  Change in K-Max measured by corneal topography, compared to baseline

  12 Months

• K-Mean

  Change in K-Mean measured by corneal topography, compared to baseline

  12 Months

Secondary Outcomes (3)

• Uncorrected Visual Acuity

  12 Months

• Best Corrected Visual Acuity

  12 Months

• Central Pachymetry

  12 Months

Study Arms (2)

Pulsed 5mW/cm2

EXPERIMENTAL

5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Pulsed 8mW/cm2

EXPERIMENTAL

8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Interventions

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution COMBINATION_PRODUCT

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Also known as: Corneal Crosslinking

Pulsed 5mW/cm2; Pulsed 8mW/cm2

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• Contact Lens Wearers Only:
• Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
• And one or more of the following:
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex, Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D
• I-S keratometry difference \> 1.5 D on the Pentacam/Orbscan map or topography map
• Posterior corneal elevation \>16 microns
• Thinnest corneal point \>300 microns

You may not qualify if:

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal thickness \< 300 microns measured by ultrasonic pachymetry or pentacam.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, etc.) Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Sponsors & Collaborators

• Cornea Associates of Texas: lead

Study Sites (1)

Cornea Associates of Texas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 14, 2020
• Study Start: February 1, 2021
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)