Trial · NCT04250207

Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

NCT04250207, Phase 2, Completed, Kowa Research Institute, Inc.; results first posted 2024-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis. Trials, record NCT04250207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04250207

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
NCT number: NCT04250207
Status: Completed
Phases: Phase 2
Enrollment: 65 participants, actual
Lead sponsor: Kowa Research Institute, Inc.
Conditions: Fuchs' Endothelial Corneal Dystrophy
Interventions: K-321 Solution, Placebo Solution
First posted: 2020-01-31
Last updated: 2024-11-05
Results first posted: 2024-11-05

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Central Corneal Endothelial Cell Density (ECD) at Week 12	Baseline to Week 12	Change in Central ECD at week 12
Secondary	Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline to Week 52
Secondary	Change From Baseline in Central Corneal Thickness	Baseline to Week 52
Secondary	Time to Achievement of no Corneal Oedema of Study Eye	Baseline to Week 52
Secondary	Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit	Baseline to Week 52
Secondary	Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	Up to 52 Weeks
Secondary	Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness	Baseline up to 52 Weeks
Secondary	Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit	Baseline to Week 52
Secondary	Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	Baseline up to Week 52
Secondary	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Baseline to Week 52

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Central Corneal Endothelial Cell Density (ECD) at Week 12	Baseline to Week 12	Full Analysis Set (FAS)	cells/mm2	MEAN
SECONDARY	Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline to Week 52	The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:~* Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.~* Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.	cells/mm2	MEAN
SECONDARY	Change From Baseline in Central Corneal Thickness	Baseline to Week 52	The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:~* Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.~* Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.	μm	MEAN
SECONDARY	Time to Achievement of no Corneal Oedema of Study Eye	Baseline to Week 52	Proportions of patients from the FAS who achieved no corneal edema of the study eye	Days	MEDIAN
SECONDARY	Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit	Baseline to Week 52	The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:~* Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.~* Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	Up to 52 Weeks		Days	MEDIAN
SECONDARY	Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness	Baseline up to 52 Weeks	The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:~* Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.~* Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit	Baseline to Week 52		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	Baseline up to Week 52		Days	MEDIAN
SECONDARY	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Baseline to Week 52	The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:~* Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, or loss to follow-up.~* Optional visits: Week 2 was an optional visit and saw a smaller number of participants contributing data to specific outcome measures.	Percent	MEAN

Source ClinicalTrials.gov

Results by group231

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Central Corneal Endothelial Cell Density (ECD) at Week 12	K-321 QID		530.86	Standard Deviation 312.453	cells/mm2
Central Corneal Endothelial Cell Density (ECD) at Week 12	K-321 BID		468.02	Standard Deviation 322.361	cells/mm2
Central Corneal Endothelial Cell Density (ECD) at Week 12	Placebo		228.05	Standard Deviation 297.860	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	K-321 QID	Baseline	440.01	Standard Deviation 774.300	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	K-321 BID	Baseline	319.06	Standard Deviation 593.294	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	Placebo	Baseline	254.27	Standard Deviation 468.027	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	K-321 QID	Week 1	0.00	Standard Deviation 0.00	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	K-321 BID	Week 1	0.05	Standard Deviation 0.218	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	Placebo	Week 1	0.05	Standard Deviation 0.213	cells/mm2
Central Corneal ECD From Baseline to Each Subsequent Visit	K-321 QID	Week 2	0.00	Standard Deviation 0.00	cells/mm2

1 to 10 of 231Source ClinicalTrials.gov

See all 231 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
12 Week Treatment	STARTED	K-321 QID	21
12 Week Treatment	STARTED	K-321 BID	22
12 Week Treatment	STARTED	Placebo	22
12 Week Treatment	COMPLETED	K-321 QID	21
12 Week Treatment	COMPLETED	K-321 BID	22
12 Week Treatment	COMPLETED	Placebo	20
12 Week Treatment	NOT COMPLETED	K-321 QID	0
12 Week Treatment	NOT COMPLETED	K-321 BID	0
12 Week Treatment	NOT COMPLETED	Placebo	2
40 Week Follow-up Observation	STARTED	K-321 QID	21

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Conjunctival hyperaemia	Eye disorders	K-321 QID	3	21
other	Conjunctival hyperaemia	Eye disorders	K-321 BID	3	22
other	Conjunctival hyperaemia	Eye disorders	Placebo	0	22
other	Corneal oedema	Eye disorders	K-321 QID	4	21
other	Corneal oedema	Eye disorders	K-321 BID	2	22
other	Corneal oedema	Eye disorders	Placebo	7	22
other	Eye pruritus	Eye disorders	K-321 QID	1	21
other	Eye pruritus	Eye disorders	K-321 BID	3	22
other	Eye pruritus	Eye disorders	Placebo	0	22
other	Vision blurred	Eye disorders	K-321 QID	1	21

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	K-321 QID	0	21
Total, all-cause mortality	K-321 BID	0	22
Total, all-cause mortality	Placebo	0	22
Total, other adverse events	K-321 QID	12	21
Total, other adverse events	K-321 BID	11	22
Total, other adverse events	Placebo	14	22
Total, serious adverse events	K-321 QID	0	21
Total, serious adverse events	K-321 BID	1	22
Total, serious adverse events	Placebo	3	22

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04250207

GET https://conductscience.org/api/trials/v1/NCT04250207/results?page=2

API reference For AI assistants