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

NCT04213885 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: PXL330-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

Conditions

Keratoconus, Unstable; Ectasia Corneal; Bacterial Keratitis

Outcome Measures

Primary Outcomes (1)

• Mean keratometry in diopters

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

  1 year

Secondary Outcomes (1)

• Best corrected visual acuity

  1 year

Study Arms (2)

Pulsed Accelerated

EXPERIMENTAL

30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Combination Product: PXL 330 Platinum device/Riboflavin

Conventional

ACTIVE COMPARATOR

9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Combination Product: PXL 330 Platinum device/Riboflavin

Interventions

PXL 330 Platinum device/Riboflavin COMBINATION_PRODUCT

30mW, 5 sec, 5 sec off, 10 minutes of illumination

Conventional; Pulsed Accelerated

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• 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
• 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
• Fleisher 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 greater than or equal to 47.2

You may not qualify if:

• Eyes classified as normal or atypical normal on the severity grading scheme
• Corneal pachymetry at the screening exam that is \<300 microns at the 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 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 the study medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.
• Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.

Sponsors & Collaborators

• Eye Specialists of Indiana: lead

Study Sites (1)

Eye Specialists of Indiana

Indianapolis, Indiana, 46220, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

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: December 27, 2019
• First Posted: December 30, 2019
• Study Start: May 4, 2020
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)