NCT04240457

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

Terminated Phase 2 Results posted Last updated 12 December 2024

What this trial tests

Phase 2 trial testing Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. in Keratoconus in 11 participants. Terminated before completion.

Timeline

8 July 2020

Primary endpoint
18 February 2023

18 February 2023

Quick facts

Lead sponsor	Arbor Center for Eye Care
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	11
Start date	8 July 2020
Primary completion	18 February 2023
Estimated completion	18 February 2023
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Keratoconus — all drugs for Keratoconus →
• Cornea Ectasia — all drugs for Cornea Ectasia →

Sponsor

Arbor Center for Eye Care

Who can join

Adults 12 to 60, any sex, with Keratoconus or Cornea Ectasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Keratometry in Diopters Primary · 1 year

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

Screening

Group	Value	95% CI
Pulsed, Accelerated	51.0	± 9.9
Conventional	49.8	± 4.8

3 months

Group	Value	95% CI
Pulsed, Accelerated	50.3	± 7.8
Conventional	49.0	± 5.6

6 months

Group	Value	95% CI
Pulsed, Accelerated	46.6	± .9
Conventional	49.1	± 5.5

12 months

Group	Value	95% CI
Pulsed, Accelerated	47.9	± 11.3
Conventional	45.8	± 4.6

Best Corrected Visual Acuity With Spectacles or Contact Lenses Secondary · 1 year

Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale. Snellen chart was used. Values closer to 20/20 indicate better vision.

Screening

Group	Value	95% CI
Pulsed, Accelerated	0
Conventional	0
Pulsed, Accelerated	0
Conventional	1
Pulsed, Accelerated	8
Conventional	2
Pulsed, Accelerated	5
Conventional	1

1 month post-procedure

Group	Value	95% CI
Pulsed, Accelerated	0
Conventional	1
Pulsed, Accelerated	6
Conventional	1
Pulsed, Accelerated	2
Conventional	1
Pulsed, Accelerated	0
Conventional	0

3 months post- procedure

Group	Value	95% CI
Pulsed, Accelerated	1
Conventional	1
Pulsed, Accelerated	6
Conventional	2
Pulsed, Accelerated	1
Conventional	0
Pulsed, Accelerated	1
Conventional	0

6 months post-procedure

Group	Value	95% CI
Pulsed, Accelerated	1
Conventional	1
Pulsed, Accelerated	5
Conventional	1
Pulsed, Accelerated	0
Conventional	1
Pulsed, Accelerated	0
Conventional	0

12 months post-procedure

Group	Value	95% CI
Pulsed, Accelerated	1
Conventional	1
Pulsed, Accelerated	1
Conventional	1
Pulsed, Accelerated	0
Conventional	1
Pulsed, Accelerated	0
Conventional	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pulsed, Accelerated

Serious: 0/7 (0%)

Deaths: 0/7

Conventional

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (1 terms — click to expand)

Reaction	System	Pulsed, Accelerated	Conventional
Photophobia	Eye disorders	—	—

Data from ClinicalTrials.gov NCT04240457 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.