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

NCT05528172 | Completed Phase 3 FDA Drug

• 1 other identifier: K-321-302
• Study Type: interventional
• Target: 331
• Locations: 2 countries
• Sites: 45

Brief Summary

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

Conditions

Corneal Edema After Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Central Corneal Endothelial Cell Density (ECD) at Week 12

  Corneal ECD measurement captured by specular microscopy

  Baseline to Week 12

Secondary Outcomes (9)

• Change in Central Corneal ECD

  Baseline to Week 26

• Change in Peripheral Corneal ECD

  Baseline to Week 26

• Change in Corneal Thickness

  Baseline to Week 26

• Change in corneal edema

  Baseline to Week 26

• Change in Best-Corrected Visual Acuity (BCVA)

  Baseline to Week 26

Study Arms (4)

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.

Drug: Ripasudil

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.

Drug: Ripasudil

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.

Drug: Placebo

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.

Drug: Placebo

Interventions

Ripasudil DRUG

K-321 ophthalmic solution

Also known as: K-321

Group A; Group B

Placebo DRUG

Placebo ophthalmic solution

Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (45)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Alvarado Eye Associates

La Mesa, California, 91942, United States

Location

SoCal Eye Physicians and Associates

Long Beach, California, 90805, United States

Location

Visionary Research Institute

Newport Beach, California, 92663, United States

Location

Pendleton Eye Center

Oceanside, California, 92056, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Premiere Practice Management, LLC

Torrance, California, 90505, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Icon Eye Care

Grand Junction, Colorado, 81501, United States

Location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

Clayton Eye Clinical Research, LLC

Morrow, Georgia, 30260, United States

Location

Durrie Vision

Overland Park, Kansas, 66210, United States

Location

Eye Care Institute/Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Maine Eye Center

Portland, Maine, 04101, United States

Location

Fraser Eye Care Center

Fraser, Michigan, 48026, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Ophthalmology Consultantants, Ltd.

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Vance Thompson Vision-MT

Bozeman, Montana, 59718, United States

Location

Vance Thompson Vision- NE

Omaha, Nebraska, 68137, United States

Location

Wellish Vision Institute

Las Vegas, Nevada, 89119, United States

Location

Center for Sight

Las Vegas, Nevada, 89145, United States

Location

NYU Grossman School of Medicine

New York, New York, 10017, United States

Location

Seeta Eye Center

Poughkeepsie, New York, 12603, United States

Location

Vance Thompson Vision ND

West Fargo, North Dakota, 58078, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Cincinnati Eye Institute

Mason, Ohio, 45040, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Keystone Research

Austin, Texas, 78751, United States

Location

Hill Country Eye Center

Cedar Park, Texas, 78613, United States

Location

Louis M. Alpern, M.D., M.P.H.,P.A.

El Paso, Texas, 79902, United States

Location

Houston Eye Associates

Houston, Texas, 77008, United States

Location

Lake Travis Eye & Laser Center

Lakeway, Texas, 78738, United States

Location

DCT-Shah Research, LLC dba Discovery Clinical Trials

Mission, Texas, 78572, United States

Location

Terry Eye Associates

San Antonio, Texas, 78212, United States

Location

Centro Oftalmologico Metropolitano

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Interventions

K-115

Study Officials

• Shona Pendse, MD, MMSc

  Kowa Pharma Development Co.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 6, 2022
• Study Start: August 4, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (44); PR (1)