Trial · NCT05255107
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
NCT05255107, Phase 2, Phase 3, Unknown, Peschke GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers. Trials, record NCT05255107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05255107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
- NCT number
- NCT05255107
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 468 participants, estimated
- Lead sponsor
- Peschke GmbH
- Conditions
- Keratitis, Corneal Ulcer
- Interventions
- Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution, Standard of Care Therapy + Sham CXL + Artificial Tears
- First posted
- 2022-02-24
- Last updated
- 2022-10-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers | Week 2 (#+/- 2 study days). | Primary Outcome Measure: 1. The composite primary endpoint outcome would be the proportion of patients in the treated group, compared to the control group, who achieve all three of the following components: * complete re-epithelialization at week 2, defined as absence of corneal fluorescein staining noted with the blue light of the slit lamp by the investigator. * no expansion of infiltrate from baseline to week 2. The size of the infiltrate will be reviewed by the investigator using the slit lamp exam and compared to baseline measures to assess expansion of the infiltrate. * a negative corneal culture at week 2 2. Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05255107
GET https://conductscience.org/api/trials/v1/NCT05255107/registered