CompletedNCT04250207Updated Nov 5, 2024Results posted

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

A Phase 2 interventional study of K-321 Solution and Placebo Solution in Fuchs' Endothelial Corneal Dystrophy, sponsored by Kowa Research Institute, Inc.. Completed at 29 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Kowa Research Institute, Inc. (part of Kowa Company, Ltd.) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 65
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Conditions studied

Fuchs' Endothelial Corneal Dystrophy

Browse trials for

Fuchs' Endothelial Dystrophy 92

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's enrollment of 65 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Kowa Research Institute, Inc. is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 9 (45%) have results posted.

Browse Kowa Research Institute, Inc. studies →All Kowa Company, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 65 participants (actual)

Study arms

Experimental
K-321 QID
K-321 Ophthalmic Solution Dose A
Drug: K-321 Solution
Experimental
K-321 BID
K-321 Ophthalmic Solution Dose B
Drug: K-321 Solution · Drug: Placebo Solution
Placebo comparator
Placebo
Vehicle Solution Dose
Drug: Placebo Solution

Interventions

DrugK-321 Solution
K-321 solution drops
DrugPlacebo Solution
Placebo solution drops for K-321

What researchers measure

Primary outcomes

Central Corneal Endothelial Cell Density (ECD) at Week 12
Change in Central ECD at week 12
Time frame: Baseline to Week 12

Secondary outcomes

Central Corneal ECD From Baseline to Each Subsequent Visit
Time frame: Baseline to Week 52
Change From Baseline in Central Corneal Thickness
Time frame: Baseline to Week 52
Time to Achievement of no Corneal Oedema of Study Eye
Time frame: Baseline to Week 52
Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
Time frame: Baseline to Week 52
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
Time frame: Up to 52 Weeks
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
Time frame: Baseline up to 52 Weeks
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
Time frame: Baseline to Week 52
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
Time frame: Baseline up to Week 52
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
Time frame: Baseline to Week 52

Results

Posted Nov 5, 2024

Participant flow

12 Week Treatment

Participant flow — 12 Week Treatment
Milestone	K-321 QID	K-321 BID	Placebo
Started	21	22	22
Completed	21	22	20
Not completed	0	0	2

40 Week Follow-up Observation

Participant flow — 40 Week Follow-up Observation
Milestone	K-321 QID	K-321 BID	Placebo
Started	21	22	22
Completed	21	21	20
Not completed	0	1	2

Outcome measures

PrimaryCentral Corneal Endothelial Cell Density (ECD) at Week 12

Change in Central ECD at week 12

Time frame:: Baseline to Week 12
Reported as:: Mean · cells/mm2

Central Corneal Endothelial Cell Density (ECD) at Week 12
cells/mm2	K-321 QID	K-321 BID	Placebo
Central Corneal Endothelial Cell Density (ECD) at Week 12	530.86 ± 312.453	468.02 ± 322.361	228.05 ± 297.860

Statistical analysis

K-321 QID vs Placebo · Other (Wilcoxon Rank Sum Test) · p = 0.0065
K-321 BID vs Placebo · Other (Wilcoxon Rank Sum Test) · p = 0.0344

SecondaryCentral Corneal ECD From Baseline to Each Subsequent Visit

Time frame:: Baseline to Week 52
Reported as:: Mean · cells/mm2

Central Corneal ECD From Baseline to Each Subsequent Visit
cells/mm2	K-321 QID	K-321 BID	Placebo
Baseline	440.01 ± 774.300	319.06 ± 593.294	254.27 ± 468.027
Week 1	0.00 ± 0.00	0.05 ± 0.218	0.05 ± 0.213
Week 2	0.00 ± 0.00	0.05 ± 0.218	0.05 ± 0.213
Week 3	131.98 ± 171.648	31.90 ± 102.749	27.49 ± 127.828
Week 5	167.36 ± 176.049	167.94 ± 218.321	104.54 ± 218.264
Week 7	303.14 ± 294.919	302.95 ± 232.956	79.38 ± 215.197
Week 9	370.71 ± 338.393	340.76 ± 310.264	156.04 ± 278.455
Week 12	530.86 ± 312.453	468.02 ± 322.361	228.05 ± 297.860
Week 16	540.52 ± 311.004	499.77 ± 358.411	286.75 ± 350.269
Week 20	655.20 ± 260.268	518.50 ± 296.094	347.21 ± 313.930
Week 24	668.22 ± 313.783	541.02 ± 328.131	386.83 ± 353.840
Week 38	722.23 ± 331.954	529.65 ± 303.691	391.10 ± 316.339
Week 52	751.45 ± 407.259	633.05 ± 313.372	431.79 ± 327.488

Statistical analysis

K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3587
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.5724
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3703
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = > 0.9999
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3703
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = > 0.9999
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0257
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.7263
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0607
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0460
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0111
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0011
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0200
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0476
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0065
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0344
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0250
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0733
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0072
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1124
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0199
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.2331
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0024
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1672
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0047
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0625

SecondaryChange From Baseline in Central Corneal Thickness

Time frame:: Baseline to Week 52
Reported as:: Mean · μm

Change From Baseline in Central Corneal Thickness
μm	K-321 QID	K-321 BID	Placebo
Week 1	265.57 ± 125.944	250.30 ± 90.448	319.33 ± 130.570
Week 2	237.54 ± 94.157	249.14 ± 90.636	315.18 ± 131.996
Week 3	96.73 ± 134.360	132.63 ± 152.920	201.68 ± 126.387
Week 5	52.71 ± 109.696	32.31 ± 110.784	159.95 ± 128.295
Week 7	42.24 ± 114.048	2.37 ± 98.340	134.83 ± 132.811
Week 9	10.36 ± 98.235	-14.23 ± 60.223	116.77 ± 141.046
Week 12	0.59 ± 86.332	-22.69 ± 61.127	100.19 ± 137.191
Week 16	2.40 ± 67.680	-9.71 ± 50.918	70.00 ± 132.908
Week 20	16.99 ± 90.440	-17.70 ± 46.593	70.52 ± 139.880
Week 24	10.60 ± 78.376	-27.80 ± 42.954	68.17 ± 147.116
Week 38	-12.32 ± 66.319	-21.40 ± 42.525	63.09 ± 149.562
Week 52	-6.74 ± 65.888	-25.88 ± 44.360	55.29 ± 155.649

Statistical analysis

K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.2434
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.2126
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0790
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3043
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0357
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0803
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0150
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0012
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0314
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0019
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0170
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0021
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0127
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0014
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0677
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0243
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1867
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0250
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3213
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0298
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1449
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0947
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.5181
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1898

SecondaryTime to Achievement of no Corneal Oedema of Study Eye

Time frame:: Baseline to Week 52
Reported as:: Median · Days

Time to Achievement of no Corneal Oedema of Study Eye
Days	K-321 QID	K-321 BID	Placebo
Time to Achievement of no Corneal Oedema of Study Eye	35.0 (22.0 to 64.0)	51.5 (50.0 to 269.0)	267.0 (141.0 to 365.0)

Statistical analysis

K-321 QID vs Placebo · Log Rank · p = 0.0021
K-321 BID vs Placebo · Log Rank · p = 0.1696

SecondaryProportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit

Time frame:: Baseline to Week 52
Reported as:: Count of participants · Participants

Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
Participants	K-321 QID	K-321 BID	Placebo
Week 1	0	0	0
Week 2	0	0	0
Week 3	0	0	0
Week 5	0	0	1
Week 7	3	0	1
Week 9	3	2	2
Week 12	6	4	2
Week 16	6	7	3
Week 20	9	7	3
Week 24	10	8	6
Week 38	12	5	3
Week 52	15	8	5

Statistical analysis

K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.4872
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.4634
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.6050
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.4762
K-321 QID vs Placebo · Chi-square or Fisher exact · p = > 0.9999
K-321 BID vs Placebo · Chi-square or Fisher exact · p = > 0.9999
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.4227
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.6796
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.4642
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.4645
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.2744
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.7026
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.7817
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.9285
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0135
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.6992
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0135
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.5154

SecondaryTime to Achieve Central Corneal ECD 700 Cells/mm2 or More

Time frame:: Up to 52 Weeks
Reported as:: Median · Days

Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
Days	K-321 QID	K-321 BID	Placebo
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	141.0 (83.0 to 363.0)	181.0 (113.0 to NA)	273.0 (135.0 to NA)

Statistical analysis

K-321 QID vs Placebo · Log Rank · p = 0.1209
K-321 BID vs Placebo · Log Rank · p = 0.7116

SecondaryNumber of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness

Time frame:: Baseline up to 52 Weeks
Reported as:: Count of participants · Participants

Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
Participants	K-321 QID	K-321 BID	Placebo
Week 1	0	0	0
Week 2	0	0	0
Week 3	5	3	1
Week 5	8	9	2
Week 7	11	13	3
Week 9	11	16	5
Week 12	13	17	5
Week 16	14	13	6
Week 20	12	14	8
Week 24	13	17	9
Week 38	15	16	10
Week 52	14	15	13

Statistical analysis

K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0915
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.3282
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0648
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0310
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0187
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0036
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0687
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0016
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0218
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0013
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0348
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.1028
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.8677
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.4401
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.5926
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0732
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.2497
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.2453
K-321 QID vs Placebo · Chi-square or Fisher exact · p = > 0.9999
K-321 BID vs Placebo · Chi-square or Fisher exact · p = > 0.9999

SecondaryProportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit

Time frame:: Baseline to Week 52
Reported as:: Count of participants · Participants

Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
Participants	K-321 QID	K-321 BID	Placebo
Week 1	0	0	0
Week 2	0	0	0
Week 3	8	0	1
Week 5	11	4	1
Week 7	11	12	2
Week 9	14	12	2
Week 12	17	12	2
Week 16	16	13	2
Week 20	15	12	7
Week 24	17	13	8
Week 38	17	13	10
Week 52	17	13	13

Statistical analysis

K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0093
K-321 BID vs Placebo · Chi-square or Fisher exact · p = > 0.9999
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0006
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.3449
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0028
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0028
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0001
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0028
K-321 QID vs Placebo · Chi-square or Fisher exact · p = < 0.0001
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0028
K-321 QID vs Placebo · Chi-square or Fisher exact · p = < 0.0001
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.0011
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0094
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.1281
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0051
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.1313
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.0268
K-321 BID vs Placebo · Chi-square or Fisher exact · p = 0.3652
K-321 QID vs Placebo · Chi-square or Fisher exact · p = 0.1854
K-321 BID vs Placebo · Chi-square or Fisher exact · p = > 0.9999

SecondaryTime to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness

Time frame:: Baseline up to Week 52
Reported as:: Median · Days

Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
Days	K-321 QID	K-321 BID	Placebo
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	50 (35.0 to 110.0)	50.0 (34.0 to 66.0)	165.0 (112.0 to 366.0)

Statistical analysis

K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0259
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0068

SecondaryPercent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit

Time frame:: Baseline to Week 52
Reported as:: Mean · Percent

Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
Percent	K-321 QID	K-321 BID	Placebo
Week 1	45.76 ± 23.191	41.48 ± 15.582	51.41 ± 21.687
Week 2	39.03 ± 10.916	36.77 ± NA	40.97 ± NA
Week 3	16.50 ± 22.581	21.85 ± 25.600	32.39 ± 20.422
Week 5	9.24 ± 19.101	5.31 ± 17.421	25.67 ± 21.873
Week 7	7.58 ± 19.744	0.43 ± 15.276	20.84 ± 22.228
Week 9	2.51 ± 18.451	-2.28 ± 9.442	14.55 ± 18.954
Week 12	0.73 ± 15.895	-3.65 ± 9.467	10.70 ± 17.611
Week 16	0.74 ± 11.936	-1.65 ± 7.955	2.91 ± 11.967
Week 20	3.85 ± 17.227	-3.64 ± 6.726	1.93 ± 14.291
Week 24	2.27 ± 14.662	-5.42 ± 5.927	2.79 ± 16.807
Week 38	-3.63 ± 7.992	-4.98 ± 5.229	-2.00 ± 9.969
Week 52	-2.90 ± 8.634	-5.63 ± 5.614	-3.68 ± 11.182

Statistical analysis

K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.4435
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.3402
K-321 QID vs K-321 BID · Wilcoxon Rank Sum Test · p = > 0.9999
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0655
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0903
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0216
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0020
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0676
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0029
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0335
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0053
K-321 QID vs K-321 BID · Wilcoxon Rank Sum Test · p = 0.0608
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.0071
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.4406
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.1716
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.9856
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.2229
K-321 QID vs K-321 BID · Wilcoxon Rank Sum Test · p = 0.8817
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.2081
K-321 QID vs Placebo · Wilcoxon Rank Sum Test · p = 0.7335
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.5367
K-321 QID vs K-321 BID · Wilcoxon Rank Sum Test · p = 0.5550
K-321 BID vs Placebo · Wilcoxon Rank Sum Test · p = 0.8718

Adverse events

Collected over 52 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
K-321 QID	0/21 (0%)	0/21 (0%)	12/21 (57.1%)
K-321 BID	0/22 (0%)	1/22 (4.5%)	11/22 (50%)
Placebo	0/22 (0%)	3/22 (13.6%)	14/22 (63.6%)

Most frequent serious events

Most frequent serious events
Event	K-321 QID	K-321 BID	Placebo
AppendicitisInfections and infestations	0/21	1/22	0/22
Pneumonia bacterialInfections and infestations	0/21	0/22	1/22
Terminal ileitisGastrointestinal disorders	0/21	0/22	1/22
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/21	0/22	1/22
Alcohol rehabilitationSurgical and medical procedures	0/21	0/22	1/22
Deep vein thrombosisVascular disorders	0/21	0/22	1/22

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	K-321 QID	K-321 BID	Placebo
Corneal oedemaEye disorders	4/21	2/22	7/22
Eye painEye disorders	0/21	2/22	5/22
Conjunctival hyperaemiaEye disorders	3/21	3/22	0/22
Eye pruritusEye disorders	1/21	3/22	0/22
Vision blurredEye disorders	1/21	2/22	3/22
Visual acuity reducedEye disorders	1/21	3/22	0/22
Eye allergy (study eye)Eye disorders	2/21	0/22	0/22
Corneal degenerationEye disorders	2/21	1/22	1/22
Eye allergy (non-study eye)Eye disorders	2/21	0/22	0/22
PhotophobiaEye disorders	1/21	2/22	2/22

Baseline characteristics

The Full Analysis Set (FAS) consist of all participants who have a successful descemetorhexis procedure performed, were randomly assigned to receive double-mask study drug, received at least one dose of study drug in the study eye, and have at least one assessment of central corneal ECD performed after the descemetorhexis procedure on the study eye.

Age, Continuous
Age, Continuous(Years)	K-321 QID	K-321 BID	Placebo	Total
Mean	64.7 ± 12.28	65.1 ± 9.68	65.3 ± 9.00	65.03 ± 10.23

Sex: Female, Male
Sex: Female, Male(Participants)	K-321 QID	K-321 BID	Placebo	Total
Female	16	13	20	49
Male	5	9	2	16

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	K-321 QID	K-321 BID	Placebo	Total
Hispanic or Latino	5	1	2	8
Not Hispanic or Latino	16	21	20	57
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	K-321 QID	K-321 BID	Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	1	0	1
Black or African American	1	1	2	4
White	20	19	20	59
More than one race	0	1	0	1
Unknown or Not Reported	0	0	0	0

Study locations

29 sites

Jules Stein Eye Institute
Los Angeles, California 90095, United States
Byers Eye Institute at Stanford
Palo Alto, California 94304, United States
UC Davis Eye Center
Sacramento, California 95817, United States
Sacramento Eye Consultants
Sacramento, California 98515, United States
Gorovoy MD Eye Specialists
Fort Myers, Florida 33907, United States
UF Health Eye Center
Gainesville, Florida 32605, United States
Chicago Cornea Consultants Ltd
Hoffman Estates, Illinois 60169, United States
Arbor Centers For Eyecare
Orland Park, Illinois 60467, United States
Price Vision Group
Indianapolis, Indiana 46260, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts 02114, United States
W Kellogg Eye Center
Ann Arbor, Michigan 48105, United States
Minnesota Eye Consultants
Bloomington, Minnesota 55431, United States
Eye Associates of New Mexico
Albuquerque, New Mexico 87109, United States
NY Langone Health
New York, New York 10017, United States
Cincinnati Eye Institute
Cincinnati, Ohio 45242, United States
Devers Eye Institute
Portland, Oregon 97210, United States
Casey Eye Institute - OHSU
Portland, Oregon 97239, United States
Vantage EyeCare, LLC
Bala-Cynwyd, Pennsylvania 19004, United States
UPMC Eye Center
Pittsburgh, Pennsylvania 15213, United States
Sydney Eye Hospital
Sydney, New South Wales 2000, Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000, Australia
Rigshospitalet - Glostrup
Glostrup, Capital 2600, Denmark
Aarhus Universitetshospital
Aarhus, 8200, Denmark
Universitätsklinikum Erlangen
Erlangen, Bayern 91054, Germany
Universität des Saarlandes
Homburg, Saarland 66421, Germany
Instituto Ophthalmologic Fernandez Vega
Oviedo, Asturias 33012, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona 08916, Spain
Instituto de Microcirugia Ocular
Barcelona, 8035, Spain
Hospital La Arruzafa
Córdoba, 14012, Spain

References and documents

Study documents

Study protocol ↗ · Aug 16, 2019
Study protocol ↗ · Dec 31, 2019
Statistical analysis plan ↗ · Feb 9, 2021
Statistical analysis plan ↗ · Aug 25, 2021
Statistical analysis plan ↗ · Jun 8, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Sep 2021, 14 months.

Results were first posted in Nov 2024, 3 years 1 month after primary completion. A results delay was requested in Sep 2022.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 16, 2020
First posted: Jan 31, 2020
StartActual: Jun 23, 2020
Primary completionActual: Sep 22, 2021
CompletionActual: Jun 27, 2022
Results delay requested: Sep 20, 2022
Results first posted: Nov 5, 2024
Last update: Nov 5, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04250207
Lead sponsor: Kowa Research Institute, Inc.
Responsible party: Sponsor
First posted: Jan 31, 2020
Start date: Jun 23, 2020
Primary completion: Sep 22, 2021
Completion: Jun 27, 2022
Results posted: Nov 5, 2024
Last update: Nov 5, 2024

Study contacts

Shona Pendse, MD, MMSc

study chair · Kowa Pharma Development Co.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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