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The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment. |
|
| Group B | Experimental | Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment. |
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| Group C | Placebo Comparator | Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment. |
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| Group D | Placebo Comparator | Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripasudil | Drug | K-321 ophthalmic solution |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Is a female subject of childbearing potential and any of the following is true:
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
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| Name | Affiliation | Role |
|---|---|---|
| Shona Pendse, MD, MMSc | Kowa Pharma Development Co. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| Schwartz Laser Eye Center |
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| Placebo | Drug | Placebo ophthalmic solution |
|
| 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 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Inland Eye Specialists | Hemet | California | 92545 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| Alvarado Eye Associates | La Mesa | California | 91942 | United States |
| SoCal Eye Physicians and Associates | Long Beach | California | 90805 | United States |
| Visionary Research Institute | Newport Beach | California | 92663 | United States |
| Pendleton Eye Center | Oceanside | California | 92056 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Premiere Practice Management, LLC | Torrance | California | 90505 | United States |
| Wolstan and Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Icon Eye Care | Grand Junction | Colorado | 81501 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| International Research Center | Tampa | Florida | 33603 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Durrie Vision | Overland Park | Kansas | 66210 | United States |
| Eye Care Institute/Butchertown Clinical Trials | Louisville | Kentucky | 40206 | United States |
| Maine Eye Center | Portland | Maine | 04101 | United States |
| Fraser Eye Care Center | Fraser | Michigan | 48026 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Ophthalmology Consultantants, Ltd. | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Vance Thompson Vision-MT | Bozeman | Montana | 59718 | United States |
| Vance Thompson Vision- NE | Omaha | Nebraska | 68137 | United States |
| Wellish Vision Institute | Las Vegas | Nevada | 89119 | United States |
| Center for Sight | Las Vegas | Nevada | 89145 | United States |
| NYU Grossman School of Medicine | New York | New York | 10017 | United States |
| Seeta Eye Center | Poughkeepsie | New York | 12603 | United States |
| Vance Thompson Vision ND | West Fargo | North Dakota | 58078 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Cincinnati Eye Institute | Mason | Ohio | 45040 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Keystone Research | Austin | Texas | 78751 | United States |
| Hill Country Eye Center | Cedar Park | Texas | 78613 | United States |
| Louis M. Alpern, M.D., M.P.H.,P.A. | El Paso | Texas | 79902 | United States |
| Houston Eye Associates | Houston | Texas | 77008 | United States |
| Lake Travis Eye & Laser Center | Lakeway | Texas | 78738 | United States |
| DCT-Shah Research, LLC dba Discovery Clinical Trials | Mission | Texas | 78572 | United States |
| Terry Eye Associates | San Antonio | Texas | 78212 | United States |
| Centro Oftalmologico Metropolitano | San Juan | 00921 | Puerto Rico |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2026 | Jun 12, 2026 | 6 |
| ID | Term |
|---|---|
| C584679 | K-115 |
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