A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
- Conditions
- Corneal Edema After Cataract Surgery
- Interventions
- Drug: Placebo
- Registration Number
- NCT05528172
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Ripasudil 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 Ripasudil Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment. Group D Placebo Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment. Group C Placebo Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.
- Primary Outcome Measures
Name Time Method Change in Central Corneal Endothelial Cell Density (ECD) at Week 12 Baseline to Week 12 Corneal ECD measurement captured by specular microscopy
- Secondary Outcome Measures
Name Time Method Change in Best-Corrected Visual Acuity (BCVA) Baseline to Week 26 Measured by ETDRS scale
Change in Vision-related quality of life Baseline to Week 26 Visual Functioning Questionnarie-25 (VFQ 25, Version 2000)
Change in Corneal Thickness Baseline to Week 26 measured in micrometers by contact ultrasound pachymetry, or optical pachymetry
Change in corneal edema Baseline to Week 26 assessed as either being present or absent during slit-lamp examination
Change in Peripheral Corneal ECD Baseline to Week 26 Corneal ECD measurement captured by specular microscopy
Change in Central Corneal ECD Baseline to Week 26 Corneal ECD measurement captured by specular microscopy
Number of Participants with Adverse Events and Treatment Emergent Adverse Events Baseline to Week 26 Coded using the MedDRA dictionary (the most recent version, ver. 24.1 or later)
Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy Baseline to Week 26 Graded as Normal or Abnormal
Safety Assessment of Intraocular Pressure (IOP) Baseline to Week 26 Results will be recorded in mm Hg
Trial Locations
- Locations (44)
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Center for Sight
🇺🇸Las Vegas, Nevada, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
Fraser Eye Care Center
🇺🇸Fraser, Michigan, United States
Inland Eye Specialists
🇺🇸Hemet, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Alvarado Eye Associates
🇺🇸La Mesa, California, United States
Pendleton Eye Center
🇺🇸Oceanside, California, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
SoCal Eye Physicians and Associates
🇺🇸Long Beach, California, United States
Visionary Research Institute
🇺🇸Newport Beach, California, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
International Research Center
🇺🇸Tampa, Florida, United States
Icon Eye Care
🇺🇸Grand Junction, Colorado, United States
Durrie Vision
🇺🇸Overland Park, Kansas, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Ophthalmology Consultantants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Vance Thompson Vision ND
🇺🇸W. Fargo, North Dakota, United States
NYU Grossman School of Medicine
🇺🇸New York, New York, United States
Seeta Eye Center
🇺🇸Poughkeepsie, New York, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Keystone Research
🇺🇸Austin, Texas, United States
Terry Eye Associates
🇺🇸San Antonio, Texas, United States
Lake Travis Eye & Laser Center
🇺🇸Lakeway, Texas, United States
Centro Oftalmologico Metropolitano
🇵🇷San Juan, Puerto Rico
Comprehensive Eye Care, Ltd.
🇺🇸Washington, Missouri, United States
Vance Thompson Vision-MT
🇺🇸Bozeman, Montana, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Premiere Practice Management, LLC
🇺🇸Torrance, California, United States
Wolstan and Goldberg Eye Associates
🇺🇸Torrance, California, United States
Louis M. Alpern, M.D., M.P.H.,P.A.
🇺🇸El Paso, Texas, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
Schwartz Laser Eye Center
🇺🇸Scottsdale, Arizona, United States
Eye Care Institute/Butchertown Clinical Trials
🇺🇸Louisville, Kentucky, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Vance Thompson Vision- NE
🇺🇸Omaha, Nebraska, United States
Cincinnati Eye Institute
🇺🇸Mason, Ohio, United States
Hill Country Eye Center
🇺🇸Cedar Park, Texas, United States