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

NCT04177082 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: PXL-330-CAT
• Study Type: interventional
• Target: 200
• 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, compared to baseline

  12 Months

• K-Mean

  Change in K-Mean, 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 6mW/cm2

EXPERIMENTAL

6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time

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

Pulsed 4mW/cm2

EXPERIMENTAL

4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute 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 4mW/cm2; Pulsed 6mW/cm2

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:
• 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 for the required period of time prior to the screening refraction:
• Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks
• Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
• 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

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 Officials

• Tyrone McCall, MD

  Cornea Associates of Texas

  PRINCIPAL INVESTIGATOR

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: November 22, 2019
• First Posted: November 26, 2019
• Study Start: January 10, 2020
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)