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

Primary Purpose

Corneal Edema After Cataract Surgery

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ripasudil
Placebo
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema After Cataract Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cornea and Cataract Consultants of Arizona
  • Schwartz Laser Eye Center
  • Inland Eye Specialists
  • United Medical Research Institute
  • Alvarado Eye Associates
  • SoCal Eye Physicians and Associates
  • Visionary Research Institute
  • Pendleton Eye Center
  • North Bay Eye Associates
  • Martel Eye Medical Group
  • Premiere Practice Management, LLC
  • Wolstan and Goldberg Eye Associates
  • Icon Eye Care
  • Eye Associates of Fort Myers
  • Levenson Eye Associates
  • International Research Center
  • Clayton Eye Clinical Research, LLC
  • Durrie Vision
  • Eye Care Institute/Butchertown Clinical Trials
  • Maine Eye Center
  • Fraser Eye Care Center
  • Silverstein Eye Centers
  • Tekwani Vision Center
  • Ophthalmology Associates
  • Ophthalmology Consultantants, Ltd.
  • Comprehensive Eye Care, Ltd.
  • Vance Thompson Vision-MT
  • Vance Thompson Vision- NE
  • Wellish Vision Institute
  • Center for Sight
  • NYU Grossman School of Medicine
  • Seeta Eye Center
  • Vance Thompson Vision ND
  • Cincinnati Eye Institute
  • Cincinnati Eye Institute
  • Eye Care Specialists
  • Vance Thompson Vision
  • Keystone Research
  • Hill Country Eye Center
  • Louis M. Alpern, M.D., M.P.H.,P.A.
  • Houston Eye Associates
  • Lake Travis Eye & Laser Center
  • DCT-Shah Research, LLC dba Discovery Clinical Trials
  • Terry Eye Associates
  • Centro Oftalmologico Metropolitano

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment.

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment.

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment.

Outcomes

Primary Outcome Measures

Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
Corneal ECD measurement captured by specular microscopy

Secondary Outcome Measures

Change in Central Corneal ECD
Corneal ECD measurement captured by specular microscopy
Change in Peripheral Corneal ECD
Corneal ECD measurement captured by specular microscopy
Change in Corneal Thickness
measured in micrometers by contact ultrasound pachymetry, or optical pachymetry
Change in corneal edema
assessed as either being present or absent during slit-lamp examination
Change in Best-Corrected Visual Acuity (BCVA)
Measured by ETDRS scale
Change in Vision-related quality of life
Visual Functioning Questionnarie-25 (VFQ 25, Version 2000)
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)
Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy
Graded as Normal or Abnormal
Safety Assessment of Intraocular Pressure (IOP)
Results will be recorded in mm Hg

Full Information

First Posted
August 25, 2022
Last Updated
October 19, 2023
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05528172
Brief Title
A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema After Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment.
Intervention Type
Drug
Intervention Name(s)
Ripasudil
Other Intervention Name(s)
K-321
Intervention Description
K-321 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
Description
Corneal ECD measurement captured by specular microscopy
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Central Corneal ECD
Description
Corneal ECD measurement captured by specular microscopy
Time Frame
Baseline to Week 26
Title
Change in Peripheral Corneal ECD
Description
Corneal ECD measurement captured by specular microscopy
Time Frame
Baseline to Week 26
Title
Change in Corneal Thickness
Description
measured in micrometers by contact ultrasound pachymetry, or optical pachymetry
Time Frame
Baseline to Week 26
Title
Change in corneal edema
Description
assessed as either being present or absent during slit-lamp examination
Time Frame
Baseline to Week 26
Title
Change in Best-Corrected Visual Acuity (BCVA)
Description
Measured by ETDRS scale
Time Frame
Baseline to Week 26
Title
Change in Vision-related quality of life
Description
Visual Functioning Questionnarie-25 (VFQ 25, Version 2000)
Time Frame
Baseline to Week 26
Title
Number of Participants with Adverse Events and Treatment Emergent Adverse Events
Description
Coded using the MedDRA dictionary (the most recent version, ver. 24.1 or later)
Time Frame
Baseline to Week 26
Title
Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy
Description
Graded as Normal or Abnormal
Time Frame
Baseline to Week 26
Title
Safety Assessment of Intraocular Pressure (IOP)
Description
Results will be recorded in mm Hg
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shona Pendse, MD, MMSc
Organizational Affiliation
Kowa Pharma Development Co.
Official's Role
Study Chair
Facility Information:
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Alvarado Eye Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
SoCal Eye Physicians and Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Visionary Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Premiere Practice Management, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Icon Eye Care
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Eye Care Institute/Butchertown Clinical Trials
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Fraser Eye Care Center
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmology Consultantants, Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Vance Thompson Vision-MT
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Vance Thompson Vision- NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Facility Name
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Center for Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Seeta Eye Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Vance Thompson Vision ND
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cincinnati Eye Institute
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Hill Country Eye Center
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Louis M. Alpern, M.D., M.P.H.,P.A.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Lake Travis Eye & Laser Center
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
DCT-Shah Research, LLC dba Discovery Clinical Trials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
Terry Eye Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Centro Oftalmologico Metropolitano
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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