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

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

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

Study Overview

• Status: Completed
• Conditions: Corneal Edema After Cataract Surgery
• Intervention / Treatment: Drug: Ripasudil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Director, Clinical Operations; Phone Number: 919-433-1600; Email: Clinical@KowaUS.com

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Centro Oftalmologico Metropolitano
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
  • California
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • La Mesa, California, United States, 91942
      • Alvarado Eye Associates
    • Long Beach, California, United States, 90805
      • SoCal Eye Physicians and Associates
    • Newport Beach, California, United States, 92663
      • Visionary Research Institute
    • Oceanside, California, United States, 92056
      • Pendleton Eye Center
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Torrance, California, United States, 90505
      • Wolstan and Goldberg Eye Associates
    • Torrance, California, United States, 90505
      • Premiere Practice Management, LLC
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • ICON Eye Care
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
    • Tampa, Florida, United States, 33603
      • International Research Center
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Durrie Vision
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Eye Care Institute/Butchertown Clinical Trials
  • Maine
    • Portland, Maine, United States, 04101
      • Maine Eye Center
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Care Center
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultantants, Ltd.
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • Montana
    • Bozeman, Montana, United States, 59718
      • Vance Thompson Vision-MT
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Vance Thompson Vision- NE
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Wellish Vision Institute
    • Las Vegas, Nevada, United States, 89145
      • Center For Sight
  • New York
    • New York, New York, United States, 10017
      • NYU Grossman School of Medicine
    • Poughkeepsie, New York, United States, 12603
      • Seeta Eye Center
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision ND
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Mason, Ohio, United States, 45040
      • Cincinnati Eye Institute
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Austin, Texas, United States, 78751
      • Keystone Research
    • Cedar Park, Texas, United States, 78613
      • Hill Country Eye Center
    • El Paso, Texas, United States, 79902
      • Louis M. Alpern, M.D., M.P.H.,P.A.
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • Lakeway, Texas, United States, 78738
      • Lake Travis Eye & Laser Center
    • Mission, Texas, United States, 78572
      • DCT-Shah Research, LLC dba Discovery Clinical Trials
    • San Antonio, Texas, United States, 78212
      • Terry Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  1. is pregnant or lactating/breastfeeding, or
  2. 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).
  3. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; K-321 ophthalmic solution; Other Names: K-321
Experimental: Group B; 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; K-321 ophthalmic solution; Other Names: K-321
Placebo Comparator: Group C; 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; Placebo ophthalmic solution
Placebo Comparator: Group D; 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; Placebo ophthalmic solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.
• Investigators: Study Chair: Shona Pendse, MD, MMSc, Kowa Pharma Development Co.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Corneal Diseases; Cataract; Corneal Edema; Capsule Opacification
• Other Study ID Numbers: K-321-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No