Fuchs Endothelial Corneal DystrophyPhase 3NCT05826353
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
A Phase 3 study testing Ripasudil in people with Fuchs Endothelial Corneal Dystrophy, run by Kowa Research Institute, Inc. at 43 sites in 6 countries.
Trial summary
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy
- What is being tested?
- Ripasudil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 43 sitesin 6 countries
- Study dates
- 11 May 2023to 24 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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)
- Has a diagnosis of FECD at Visit 1
- Meet all other inclusion criteria outlined in the 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
- is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
- Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
United States21 sites
Eye Associates of New Mexico - Albuquerque - Northside
Albuquerque, New Mexico, 87109
W Kellogg Eye Center
Ann Arbor, Michigan, 48105
Cincinnati Eye Institute-1945 Cei Dr
Blue Ash, Ohio, 45242
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Gorovoy MD Eye Specialists
Fort Myers, Florida, 33907
Verdier Eye Center
Grand Rapids, Michigan, 49546
Houston Eye Associates
Houston, Texas, 77025
University of Kentucky
Lexington, Kentucky, 40508
Keck Hospital of USC
Los Angeles, California, 90033
Macy Eye Center
Los Angeles, California, 90048
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
NYU Langone Health
New York, New York, 10017
Vance Thompson Vision - Omaha
Omaha, Nebraska, 68137
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33136
Byers Eye Institute at Stanford
Palo Alto, California, 94303
Devers Eye Institute
Portland, Oregon, 97210
Sacramento Eye Consultants
Sacramento, California, 95815
R and R Eye Research, LLC.
San Antonio, Texas, 78229
Vance Thompson Vision West Fargo
West Fargo, North Dakota, 58078
Grene Vision Group-Wichita
Wichita, Kansas, 67208
Germany7 sites
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50931
Universitatsklinikum Dusseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen, Bavaria, 91054
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 91054
Universität des Saarlandes
Homburg, Saarland, 66424
LMU Klinikum der Universität
München, 81377
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Spain7 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Oftalvist - Barcelona
Barcelona, 08017
Institut Catala de Retina (ICR)
Barcelona, 08022
Instituto de Microcirugia Ocular
Barcelona, 08035
Hospital Arruzafa
Córdoba, Córdoba, 14012
Althaia Xarxa Assistencial Universitaria Manresa
Manresa, Barcelona, 17001
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, 33012
Canada3 sites
Prism Eye Institute - Mississauga-Oakville
Oakville, Ontario, L5L 1W8
Precision Cornea Centre
Ottawa, Ontario, K1G 5L1
Dr. Greg Moloney
Vancouver, British Columbia, 2000
United Kingdom3 sites
The Royal Liverpool University Hospital
Liverpool, Lancashire, L7 8XP
Moorfields Eye Hospital
London, London, City of, EC1V 2PD
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Denmark2 sites
Aarhus Universitetshospital
Aarhus N, Central Jutland, 8200
Rigshospitalet Glostrup-Valdemar Hansens Vej 1-23
Glostrup Municipality, Capital, 2600
About this study
Official title: A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Being tested
- Ripasudil, Placebo
- Medical subject headings
- Fuchs' Endothelial Dystrophy
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 group | Role | What they receive |
|---|---|---|
| K-321 | Experimental | K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase Receives: Drug: Ripasudil |
| Placebo | Placebo comparator | Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Measured: Baseline to Week 12
Secondary outcomes (5)
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Measured: Baseline to Week 12
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Measured: Baseline to Week 12
Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12
Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Measured: Week 12
Time to achievement of no corneal edema during the first 12 weeks
Measured: Baseline to Week 12
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start11 May 2023
- Primary completion17 Jan 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs Endothelial Corneal DystrophyStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shona Pendse, MD, MMSc, Study chair, Kowa Pharma Development Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826353
- Sponsor's protocol ID
- K-321-303
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
- ClinicalTrials.gov ID
- NCT05826353
- Acronym / sponsor ID
- K-321-303
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-321 | Experimental | Drug: RipasudilK-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of FECD at Visit 1
- Meet all other inclusion criteria outlined in the Clinical Study Protocol.
Key exclusion criteria (4 listed)
- Is a female subject of childbearing potential and any of the following is true:
- Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RipasudilAlso: K-321K-321 ophthalmic solution | Drug | K-321 |
| PlaceboPlacebo ophthalmic solution | Drug | Placebo |
Primary outcome
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time frame: Baseline to Week 12
5 secondary outcomes
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time frame: Baseline to Week 12
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time frame: Baseline to Week 12
Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12
Time frame: Week 12
Time to achievement of no corneal edema during the first 12 weeks
Time frame: Baseline to Week 12
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Fuchs Endothelial Corneal Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shona Pendse, MD, MMSc study chair
Kowa Pharma Development Co.
43 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ripasudil in people with Fuchs Endothelial Corneal Dystrophy, run by Kowa Research Institute, Inc. at 43 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Spain, Canada, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.