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

NCT04094090 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PXL-2211
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Conditions

Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Ectasia

Outcome Measures

Primary Outcomes (1)

• Best-contact corrected visual acuity (BSCVA)

  Change in BSCVA compared to baseline.

  3, 6, and 12 months

Secondary Outcomes (2)

• Uncorrected visual acuity

  3, 6, and 12 months

• Keratometry

  1 year

Study Arms (2)

Pulsed, accelerated

EXPERIMENTAL

4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

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

Pusled, accelerated

EXPERIMENTAL

8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

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, accelerated; Pusled, accelerated

Eligibility Criteria

• Age: 10 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 and 1 or more of the following criteria will be considered candidates for this study:
• years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. 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
• Apical Corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference \> 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \>300 microns 9. Contact Lens Wearers Only:
• a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks

You may not qualify if:

• All subjects meeting any of the following criteria will be excluded from this study:
• 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, acanthomeoeba, 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

• Goodman Eye Center: lead

Study Sites (1)

Goodman Eye Center

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective, double-armed, randomized, single study.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 18, 2019
• Study Start: October 19, 2019
• Primary Completion (Estimated): October 19, 2029
• Study Completion (Estimated): October 19, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)