Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
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ClinicalTrials.gov Identifier: NCT04250207 |
Recruitment Status :
Completed
First Posted : January 31, 2020
Last Update Posted : September 22, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fuchs' Endothelial Corneal Dystrophy | Drug: K-321 Solution Drug: Placebo Solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy |
Actual Study Start Date : | June 23, 2020 |
Actual Primary Completion Date : | September 22, 2021 |
Actual Study Completion Date : | June 27, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: K-321 QID
K-321 Ophthalmic Solution Dose A
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Drug: K-321 Solution
K-321 solution drops |
Experimental: K-321 BID
K-321 Ophthalmic Solution Dose B
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Drug: K-321 Solution
K-321 solution drops Drug: Placebo Solution Placebo solution drops for K-321 |
Placebo Comparator: Placebo
Vehicle Solution Dose
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Drug: Placebo Solution
Placebo solution drops for K-321 |
- Corneal Central ECD Measure at 12 weeks [ Time Frame: 12 Weeks ]Change in Central Endothelial Cell Density
- Safety Assessment [ Time Frame: 52 Weeks ]Number of participants with at least one adverse event

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 clinical study protocol.
Exclusion Criteria:
- Has a study eye with a history of cataract surgery within 90 days of Visit 1.
- Has a study eye with a history of any previous ocular surgery other than for cataract.
- Meet any other exclusion criteria outlined in clinical study protocol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250207

Study Chair: | Shona Pendse, MD, MMSc | Kowa Pharma Development Co. |
Responsible Party: | Kowa Research Institute, Inc. |
ClinicalTrials.gov Identifier: | NCT04250207 |
Other Study ID Numbers: |
K-321-201 |
First Posted: | January 31, 2020 Key Record Dates |
Last Update Posted: | September 22, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Corneal Dystrophies, Hereditary Fuchs' Endothelial Dystrophy Corneal Diseases Eye Diseases |
Eye Diseases, Hereditary Genetic Diseases, Inborn Pharmaceutical Solutions |