Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

NCT04240457 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 330019
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Conditions

Keratoconus; Cornea Ectasia

Outcome Measures

Primary Outcomes (1)

• Mean Keratometry in Diopters

  Average keratometry across the anterior topography of the cornea computed by a validated topographer

  1 year

Secondary Outcomes (1)

• Best Corrected Visual Acuity With Spectacles or Contact Lenses

  1 year

Study Arms (2)

Pulsed, accelerated

EXPERIMENTAL

18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.

Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.

Conventional

ACTIVE COMPARATOR

9mW continuous, 10 minutes of illumination.

Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.

Interventions

Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. COMBINATION_PRODUCT

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.

Conventional; Pulsed, accelerated

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects who have one or both eyes that meet criteria 1 and one or more of the following criteria will be considered candidates for this study:
• years of age or older
• 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 map

You may not qualify if:

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
• 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, acanthamoeba, 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

• Arbor Center for Eye Care: lead

Study Sites (1)

Arbor Center for Eye Care

Orland Park, Illinois, 60467, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Results Point of Contact

• Title: David Lubeck, MD
• Organization: ChicagoArbor Eye Care

david.lubeck@chicagoarboreye.com

708-798-6633

Study Officials

• David Lubeck, MD

  Arbor Center for Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomized at outset
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment of patients with disease

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: July 8, 2020
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: December 12, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)