A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery

Official Title
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A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Treatment and 14-week Extension, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

Conditions
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Corneal Edema After Cataract Surgery

Intervention / Treatment
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* Drug: Ripasudil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years old at the screening visit (Visit 1). Is planning to undergo cataract surgery in the study eye and has had cataract surgery at Visit 2. Can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed. Meet all other inclusion criteria outlined in clinical study protocol. Exclusion Criteria: Is a female subject of childbearing potential and any of the following is true: is pregnant or lactating/breastfeeding, or has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). has a positive urine pregnancy test result at Visit 2 before cataract surgery. Had intraocular surgery (non-laser surgery) in the study eye within 6 months of Visit 1. Had intraocular laser surgery in the study eye within 3 months of Visit 1. Meet any other exclusion criteria outlined in clinical study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment. | Drug: Ripasudil<br>* K-321 ophthalmic solution<br>* Other names: K-321;|
| Experimental: Group B<br>Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment. | Drug: Ripasudil<br>* K-321 ophthalmic solution<br>* Other names: K-321;|
| Placebo Comparator: Group C<br>Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment. | Drug: Placebo<br>* Placebo ophthalmic solution<br>|
| Placebo Comparator: Group D<br>Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment. | Drug: Placebo<br>* Placebo ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central Corneal Endothelial Cell Density (ECD) at Week 12 | Corneal ECD measurement captured by specular microscopy | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central Corneal ECD | Corneal ECD measurement captured by specular microscopy | Baseline to Week 26 | 
| Change in Peripheral Corneal ECD | Corneal ECD measurement captured by specular microscopy | Baseline to Week 26 | 
| Change in Corneal Thickness | measured in micrometers by contact ultrasound pachymetry, or optical pachymetry | Baseline to Week 26 | 
| Change in corneal edema | assessed as either being present or absent during slit-lamp examination | Baseline to Week 26 | 
| Change in Best-Corrected Visual Acuity (BCVA) | Measured by ETDRS scale | Baseline to Week 26 | 
| Change in Vision-related quality of life | Visual Functioning Questionnarie-25 (VFQ 25, Version 2000) | Baseline to Week 26 | 
| Number of Participants with Adverse Events and Treatment Emergent Adverse Events | Coded using the MedDRA dictionary (the most recent version, ver. 24.1 or later) | Baseline to Week 26 | 
| Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy | Graded as Normal or Abnormal | Baseline to Week 26 | 
| Safety Assessment of Intraocular Pressure (IOP) | Results will be recorded in mm Hg | Baseline to Week 26 |