Corneal Edema After Cataract SurgeryPhase 3NCT05528172

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

A Phase 3 study testing Ripasudil in people with Corneal Edema After Cataract Surgery, run by Kowa Research Institute, Inc. at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Corneal Edema After Cataract Surgery
What is being tested?: Ripasudil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 330 participants
Where: 45 sitesin 2 countries
Study dates: 4 Aug 2022to 22 Jun 2023
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

45 sites in 2 countries.

Country

City, postcode or hospital

45 sites in 2 countries

United States44 sites

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

Other trials in United States

Puerto Rico1 site

Centro Oftalmologico Metropolitano
San Juan, 00921

Other trials in Puerto Rico

About this study

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

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
Being tested: Ripasudil, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RipasudilDrug
Also called K-321
K-321 ophthalmic solution
PlaceboDrug
Placebo ophthalmic solution

Study groups in NCT05528172
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12
Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Measured: Baseline to Week 12

Secondary outcomes (11)

Change From Baseline in Central Corneal ECD at Each Visit
Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Measured: Baseline to Week 26
Change From Baseline in Peripheral Corneal ECD (Nasal)
Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Measured: Baseline to Week 26
Change From Baseline in Peripheral Corneal ECD (Temporal)
Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Measured: Baseline to Week 26
Change From Baseline in Central Corneal Thickness
Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm)
Measured: Baseline to Week 26
Number of Subjects With No Evidence of Corneal Edema
Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location.
Measured: Baseline to Week 26
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
Measured: Baseline to Week 26
Change From Baseline in VFQ-25 (Overall)
Visual Function assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), a patient-reported measure of vision-related functioning and quality of life.
Scores range from 0 to 100, with higher scores indicating better visual function and lower scores indicating worse visual function. The total composite score is derived from multiple subscales using the standard VFQ-25 scoring method.
Measured: Baseline to Week 26
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Shift in slit-lamp biomicroscopy findings of the study eye categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline.
- Baseline to Post-Baseline Shift
Measured: Baseline to Week 26
Shifts in Slit-lamp Biomicroscopy (Cornea)
Shift in slit-lamp biomicroscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline.
Baseline to Post-Baseline Shift
Measured: Baseline to Week 26
Shifts in Dilated Fundoscopy (Central Retina)
Shift in dilated fundoscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline.
Baseline to Post-Baseline Shift
Measured: Baseline to Week 26
Change From Baseline in Intraocular Pressure (mmHg)
Intraocular pressure (IOP) of the study eye, measured using either a contact or non-contact tonometer, and recorded in millimeters of mercury (mm Hg).
Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202222 Jun 2023

First posted6 Sep 2022
Study start4 Aug 2022
Primary completion22 Jun 2023
Study completion22 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Corneal Edema After Cataract SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05528172
Sponsor's protocol ID: K-321-302
Status last verified: Aug 2026
First submitted: 25 Aug 2022
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No