Trial · NCT05528172
A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
NCT05528172, Phase 3, Completed, Kowa Research Institute, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery. Trials, record NCT05528172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05528172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
- NCT number
- NCT05528172
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Kowa Research Institute, Inc.
- Conditions
- Corneal Edema After Cataract Surgery
- Interventions
- Ripasudil, Placebo
- First posted
- 2022-09-06
- Last updated
- 2026-09-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12 | Baseline to Week 12 | Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Secondary | Change From Baseline in Central Corneal ECD at Each Visit | Baseline to Week 26 | Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Secondary | Change From Baseline in Peripheral Corneal ECD (Nasal) | Baseline to Week 26 | Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Secondary | Change From Baseline in Peripheral Corneal ECD (Temporal) | Baseline to Week 26 | Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Secondary | Change From Baseline in Central Corneal Thickness | Baseline to Week 26 | Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm) |
| Secondary | Number of Subjects With No Evidence of Corneal Edema | Baseline to Week 26 | Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location. |
| Secondary | Change From Baseline in Best-Corrected Visual Acuity (BCVA) | Baseline to Week 26 | Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. |
| Secondary | Change From Baseline in VFQ-25 (Overall) | Baseline to Week 26 | Visual Function assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), a patient-reported measure of vision-related functioning and quality of life. Scores range from 0 to 100, with higher scores indicating better visual function and lower scores indicating worse visual function. The total composite score is derived from multiple subscales using the standard VFQ-25 scoring method. |
| Secondary | Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva) | Baseline to Week 26 | Shift in slit-lamp biomicroscopy findings of the study eye categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. \- Baseline to Post-Baseline Shift |
| Secondary | Shifts in Slit-lamp Biomicroscopy (Cornea) | Baseline to Week 26 | Shift in slit-lamp biomicroscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT05528172
GET https://conductscience.org/api/trials/v1/NCT05528172/registered