Clinical trial NCT05528172: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Corneal Edema After Cataract Surgery
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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:

  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

Primary outcomes:
measure: Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in Central Corneal ECD
timeFrame: Baseline to Week 26
measure: Change in Peripheral Corneal ECD
timeFrame: Baseline to Week 26
measure: Change in Corneal Thickness
timeFrame: Baseline to Week 26
measure: Change in corneal edema
timeFrame: Baseline to Week 26
measure: Change in Best-Corrected Visual Acuity (BCVA)
timeFrame: Baseline to Week 26
measure: Change in Vision-related quality of life
timeFrame: Baseline to Week 26
measure: Number of Participants with Adverse Events and Treatment Emergent Adverse Events
timeFrame: Baseline to Week 26
measure: Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy
timeFrame: Baseline to Week 26
measure: Safety Assessment of Intraocular Pressure (IOP)
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: La Mesa
country: United States
facility: Alvarado Eye Associates
state: California
city: Long Beach
country: United States
facility: SoCal Eye Physicians and Associates
state: California
city: Newport Beach
country: United States
facility: Visionary Research Institute
state: California
city: Oceanside
country: United States
facility: Pendleton Eye Center
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Torrance
country: United States
facility: Premiere Practice Management, LLC
state: California
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Grand Junction
country: United States
facility: Icon Eye Care
state: Colorado
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Louisville
country: United States
facility: Eye Care Institute/Butchertown Clinical Trials
state: Kentucky
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultantants, Ltd.
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Bozeman
country: United States
facility: Vance Thompson Vision-MT
state: Montana
city: Omaha
country: United States
facility: Vance Thompson Vision- NE
state: Nebraska
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Las Vegas
country: United States
facility: Center for Sight
state: Nevada
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: Poughkeepsie
country: United States
facility: Seeta Eye Center
state: New York
city: W. Fargo
country: United States
facility: Vance Thompson Vision ND
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Mason
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Cedar Park
country: United States
facility: Hill Country Eye Center
state: Texas
city: El Paso
country: United States
facility: Louis M. Alpern, M.D., M.P.H.,P.A.
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye & Laser Center
state: Texas
city: Mission
country: United States
facility: DCT-Shah Research, LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Terry Eye Associates
state: Texas
city: San Juan
country: Puerto Rico
facility: Centro Oftalmologico Metropolitano
Study officials:
affiliation: Kowa Pharma Development Co.
name: Shona Pendse, MD, MMSc
role: STUDY_CHAIR
References: