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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04250207

Enrollment

Registered

2020-01-31

Start date

2020-06-23

Completion date

2022-06-27

Last updated

2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Corneal Dystrophy

Brief summary

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

Interventions

DRUGK-321 Solution

K-321 solution drops

DRUGPlacebo Solution

Placebo solution drops for K-321

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Denmark, Germany, Spain, United States

Participant flow

Pre-assignment details

After obtaining informed consent at Visit 1, the investigator selected one eye as the study eye, and the patient returned for the descemetorhexis operation and random assignment to treatment after 1 to 4 weeks (Visit 2). At Visit 2, eligibility for study participation was confirmed, which included the requirement of a successful descemetorhexis operation which met the inclusion criteria. After eligibility was confirmed, patients were randomly assigned to the 3 treatment groups in a 1:1:1 ratio.

Participants by arm

Arm	Count
K-321 QID K-321 ophthalmic solution 4 times daily for 12 Weeks (Morning, Mid-day, Evening, Night).	21
K-321 BID K-321 ophthalmic solution twice daily for 12 Weeks. (Morning: K-321, Mid-day: Placebo, Evening: Placebo, Night: K-321)	22
Placebo Placebo ophthalmic solution four times daily for 12 Weeks. (Morning, Mid-day, Evening, Night)	22
Total	65

Baseline characteristics

Characteristic	K-321 QID	K-321 BID	Placebo	Total
Age, Continuous	64.7 Years STANDARD_DEVIATION 12.28	65.1 Years STANDARD_DEVIATION 9.68	65.3 Years STANDARD_DEVIATION 9	65.03 Years STANDARD_DEVIATION 10.23
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	1 Participants	2 Participants	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants	21 Participants	20 Participants	57 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	2 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	20 Participants	19 Participants	20 Participants	59 Participants
Sex: Female, Male Female	16 Participants	13 Participants	20 Participants	49 Participants
Sex: Female, Male Male	5 Participants	9 Participants	2 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 22	0 / 22
other Total, other adverse events	12 / 21	11 / 22	14 / 22
serious Total, serious adverse events	0 / 21	1 / 22	3 / 22

Outcome results

Primary

Central Corneal Endothelial Cell Density (ECD) at Week 12

Change in Central ECD at week 12

Time frame: Baseline to Week 12

Population: Full Analysis Set (FAS)

Arm	Measure	Value (MEAN)	Dispersion
K-321 QID	Central Corneal Endothelial Cell Density (ECD) at Week 12	530.86 cells/mm2	Standard Deviation 312.453
K-321 BID	Central Corneal Endothelial Cell Density (ECD) at Week 12	468.02 cells/mm2	Standard Deviation 322.361
Placebo	Central Corneal Endothelial Cell Density (ECD) at Week 12	228.05 cells/mm2	Standard Deviation 297.86

p-value: 0.0065Other (Wilcoxon Rank Sum Test)

p-value: 0.0344Other (Wilcoxon Rank Sum Test)

Secondary

Central Corneal ECD From Baseline to Each Subsequent Visit

Time frame: Baseline to Week 52

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 38	722.23 cells/mm2	Standard Deviation 331.954
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 16	540.52 cells/mm2	Standard Deviation 311.004
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 7	303.14 cells/mm2	Standard Deviation 294.919
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 2	0.00 cells/mm2	Standard Deviation 0
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 12	530.86 cells/mm2	Standard Deviation 312.453
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 9	370.71 cells/mm2	Standard Deviation 338.393
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline	440.01 cells/mm2	Standard Deviation 774.3
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 1	0.00 cells/mm2	Standard Deviation 0
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 24	668.22 cells/mm2	Standard Deviation 313.783
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 3	131.98 cells/mm2	Standard Deviation 171.648
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 52	751.45 cells/mm2	Standard Deviation 407.259
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 20	655.20 cells/mm2	Standard Deviation 260.268
K-321 QID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 5	167.36 cells/mm2	Standard Deviation 176.049
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 9	340.76 cells/mm2	Standard Deviation 310.264
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline	319.06 cells/mm2	Standard Deviation 593.294
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 1	0.05 cells/mm2	Standard Deviation 0.218
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 2	0.05 cells/mm2	Standard Deviation 0.218
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 3	31.90 cells/mm2	Standard Deviation 102.749
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 5	167.94 cells/mm2	Standard Deviation 218.321
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 7	302.95 cells/mm2	Standard Deviation 232.956
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 12	468.02 cells/mm2	Standard Deviation 322.361
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 16	499.77 cells/mm2	Standard Deviation 358.411
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 20	518.50 cells/mm2	Standard Deviation 296.094
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 24	541.02 cells/mm2	Standard Deviation 328.131
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 38	529.65 cells/mm2	Standard Deviation 303.691
K-321 BID	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 52	633.05 cells/mm2	Standard Deviation 313.372
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 16	286.75 cells/mm2	Standard Deviation 350.269
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 3	27.49 cells/mm2	Standard Deviation 127.828
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 38	391.10 cells/mm2	Standard Deviation 316.339
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 20	347.21 cells/mm2	Standard Deviation 313.93
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 2	0.05 cells/mm2	Standard Deviation 0.213
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline	254.27 cells/mm2	Standard Deviation 468.027
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 24	386.83 cells/mm2	Standard Deviation 353.84
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 9	156.04 cells/mm2	Standard Deviation 278.455
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 7	79.38 cells/mm2	Standard Deviation 215.197
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 1	0.05 cells/mm2	Standard Deviation 0.213
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 12	228.05 cells/mm2	Standard Deviation 297.86
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 5	104.54 cells/mm2	Standard Deviation 218.264
Placebo	Central Corneal ECD From Baseline to Each Subsequent Visit	Week 52	431.79 cells/mm2	Standard Deviation 327.488

Comparison: Baselinep-value: 0.3587Wilcoxon Rank Sum Test

Comparison: Baselinep-value: 0.5724Wilcoxon Rank Sum Test

Comparison: Week 1p-value: 0.3703Wilcoxon Rank Sum Test

Comparison: Week 1p-value: >0.9999Wilcoxon Rank Sum Test

Comparison: Week 2p-value: 0.3703Wilcoxon Rank Sum Test

Comparison: Week 2p-value: >0.9999Wilcoxon Rank Sum Test

Comparison: Week 3p-value: 0.0257Wilcoxon Rank Sum Test

p-value: 0.7263Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.0607Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.046Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0111Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0011Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.02Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.0476Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0065Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0344Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.025Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.0733Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.0072Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.1124Wilcoxon Rank Sum Test

Comparison: Week 24p-value: 0.0199Wilcoxon Rank Sum Test

Comparison: Week 24p-value: 0.2331Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.0024Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.1672Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.0047Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.0625Wilcoxon Rank Sum Test

Secondary

Change From Baseline in Central Corneal Thickness

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 1	265.57 μm	Standard Deviation 125.944
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 2	237.54 μm	Standard Deviation 94.157
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 3	96.73 μm	Standard Deviation 134.36
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 5	52.71 μm	Standard Deviation 109.696
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 7	42.24 μm	Standard Deviation 114.048
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 9	10.36 μm	Standard Deviation 98.235
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 12	0.59 μm	Standard Deviation 86.332
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 16	2.40 μm	Standard Deviation 67.68
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 20	16.99 μm	Standard Deviation 90.44
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 24	10.60 μm	Standard Deviation 78.376
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 38	-12.32 μm	Standard Deviation 66.319
K-321 QID	Change From Baseline in Central Corneal Thickness	Week 52	-6.74 μm	Standard Deviation 65.888
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 52	-25.88 μm	Standard Deviation 44.36
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 1	250.30 μm	Standard Deviation 90.448
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 12	-22.69 μm	Standard Deviation 61.127
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 20	-17.70 μm	Standard Deviation 46.593
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 2	249.14 μm	Standard Deviation 90.636
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 9	-14.23 μm	Standard Deviation 60.223
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 38	-21.40 μm	Standard Deviation 42.525
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 3	132.63 μm	Standard Deviation 152.92
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 16	-9.71 μm	Standard Deviation 50.918
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 7	2.37 μm	Standard Deviation 98.34
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 5	32.31 μm	Standard Deviation 110.784
K-321 BID	Change From Baseline in Central Corneal Thickness	Week 24	-27.80 μm	Standard Deviation 42.954
Placebo	Change From Baseline in Central Corneal Thickness	Week 5	159.95 μm	Standard Deviation 128.295
Placebo	Change From Baseline in Central Corneal Thickness	Week 7	134.83 μm	Standard Deviation 132.811
Placebo	Change From Baseline in Central Corneal Thickness	Week 24	68.17 μm	Standard Deviation 147.116
Placebo	Change From Baseline in Central Corneal Thickness	Week 9	116.77 μm	Standard Deviation 141.046
Placebo	Change From Baseline in Central Corneal Thickness	Week 12	100.19 μm	Standard Deviation 137.191
Placebo	Change From Baseline in Central Corneal Thickness	Week 16	70.00 μm	Standard Deviation 132.908
Placebo	Change From Baseline in Central Corneal Thickness	Week 38	63.09 μm	Standard Deviation 149.562
Placebo	Change From Baseline in Central Corneal Thickness	Week 1	319.33 μm	Standard Deviation 130.57
Placebo	Change From Baseline in Central Corneal Thickness	Week 2	315.18 μm	Standard Deviation 131.996
Placebo	Change From Baseline in Central Corneal Thickness	Week 20	70.52 μm	Standard Deviation 139.88
Placebo	Change From Baseline in Central Corneal Thickness	Week 3	201.68 μm	Standard Deviation 126.387
Placebo	Change From Baseline in Central Corneal Thickness	Week 52	55.29 μm	Standard Deviation 155.649

Comparison: Week 1p-value: 0.2434Wilcoxon Rank Sum Test

Comparison: Week 1p-value: 0.2126Wilcoxon Rank Sum Test

Comparison: Week 2p-value: 0.079Wilcoxon Rank Sum Test

Comparison: Week 2p-value: 0.3043Wilcoxon Rank Sum Test

Comparison: Week 3p-value: 0.0357Wilcoxon Rank Sum Test

Comparison: Week 3p-value: 0.0803Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.015Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.0012Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0314Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0019Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.017Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.0021Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0127Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0014Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.0677Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.0243Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.1867Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.025Wilcoxon Rank Sum Test

Comparison: Week 24p-value: 0.3213Wilcoxon Rank Sum Test

Comparison: Week 24p-value: 0.0298Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.1449Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.0947Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.5181Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.1898Wilcoxon Rank Sum Test

Secondary

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

Time frame: Baseline up to 52 Weeks

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

Comparison: Week 3p-value: 0.0915Chi-square or Fisher exact

Comparison: Week 3p-value: 0.3282Chi-square or Fisher exact

Comparison: Week 5p-value: 0.0648Chi-square or Fisher exact

Comparison: Week 5p-value: 0.031Chi-square or Fisher exact

Comparison: Week 7p-value: 0.0187Chi-square or Fisher exact

Comparison: Week 7p-value: 0.0036Chi-square or Fisher exact

Comparison: Week 9p-value: 0.0687Chi-square or Fisher exact

Comparison: Week 9p-value: 0.0016Chi-square or Fisher exact

Comparison: Week 12p-value: 0.0218Chi-square or Fisher exact

Comparison: Week 12p-value: 0.0013Chi-square or Fisher exact

Comparison: Week 16p-value: 0.0348Chi-square or Fisher exact

Comparison: Week 16p-value: 0.1028Chi-square or Fisher exact

Comparison: Week 20p-value: 0.8677Chi-square or Fisher exact

Comparison: Week 20p-value: 0.4401Chi-square or Fisher exact

Comparison: Week 24p-value: 0.5926Chi-square or Fisher exact

Comparison: Week 24p-value: 0.0732Chi-square or Fisher exact

Comparison: Week 38p-value: 0.2497Chi-square or Fisher exact

Comparison: Week 38p-value: 0.2453Chi-square or Fisher exact

Comparison: Week 52p-value: >0.9999Chi-square or Fisher exact

Secondary

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

Time frame: Baseline to Week 52

Arm	Measure	Group	Value (MEAN)	Dispersion
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 1	45.76 Percent	Standard Deviation 23.191
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 2	39.03 Percent	Standard Deviation 10.916
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 3	16.50 Percent	Standard Deviation 22.581
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 5	9.24 Percent	Standard Deviation 19.101
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 7	7.58 Percent	Standard Deviation 19.744
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 9	2.51 Percent	Standard Deviation 18.451
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 12	0.73 Percent	Standard Deviation 15.895
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 16	0.74 Percent	Standard Deviation 11.936
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 20	3.85 Percent	Standard Deviation 17.227
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 24	2.27 Percent	Standard Deviation 14.662
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 38	-3.63 Percent	Standard Deviation 7.992
K-321 QID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 52	-2.90 Percent	Standard Deviation 8.634
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 52	-5.63 Percent	Standard Deviation 5.614
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 1	41.48 Percent	Standard Deviation 15.582
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 12	-3.65 Percent	Standard Deviation 9.467
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 20	-3.64 Percent	Standard Deviation 6.726
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 2	36.77 Percent	—
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 9	-2.28 Percent	Standard Deviation 9.442
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 38	-4.98 Percent	Standard Deviation 5.229
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 3	21.85 Percent	Standard Deviation 25.6
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 16	-1.65 Percent	Standard Deviation 7.955
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 7	0.43 Percent	Standard Deviation 15.276
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 5	5.31 Percent	Standard Deviation 17.421
K-321 BID	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 24	-5.42 Percent	Standard Deviation 5.927
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 5	25.67 Percent	Standard Deviation 21.873
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 7	20.84 Percent	Standard Deviation 22.228
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 24	2.79 Percent	Standard Deviation 16.807
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 9	14.55 Percent	Standard Deviation 18.954
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 12	10.70 Percent	Standard Deviation 17.611
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 16	2.91 Percent	Standard Deviation 11.967
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 38	-2.00 Percent	Standard Deviation 9.969
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 1	51.41 Percent	Standard Deviation 21.687
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 2	40.97 Percent	—
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 20	1.93 Percent	Standard Deviation 14.291
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 3	32.39 Percent	Standard Deviation 20.422
Placebo	Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Week 52	-3.68 Percent	Standard Deviation 11.182

Comparison: Week 1p-value: 0.4435Wilcoxon Rank Sum Test

Comparison: Week 1p-value: 0.3402Wilcoxon Rank Sum Test

Comparison: Week 2p-value: >0.9999Wilcoxon Rank Sum Test

Comparison: Week 3p-value: 0.0655Wilcoxon Rank Sum Test

Comparison: Week 3p-value: 0.0903Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.0216Wilcoxon Rank Sum Test

Comparison: Week 5p-value: 0.002Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0676Wilcoxon Rank Sum Test

Comparison: Week 7p-value: 0.0029Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.0335Wilcoxon Rank Sum Test

Comparison: Week 9p-value: 0.0053Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0608Wilcoxon Rank Sum Test

Comparison: Week 12p-value: 0.0071Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.4406Wilcoxon Rank Sum Test

Comparison: Week 16p-value: 0.1716Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.9856Wilcoxon Rank Sum Test

Comparison: Week 20p-value: 0.2229Wilcoxon Rank Sum Test

Comparison: Week 24p-value: 0.8817Wilcoxon Rank Sum Test

p-value: 0.2081Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.7335Wilcoxon Rank Sum Test

Comparison: Week 38p-value: 0.5367Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.555Wilcoxon Rank Sum Test

Comparison: Week 52p-value: 0.8718Wilcoxon Rank Sum Test

Secondary

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

Time frame: Baseline to Week 52

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

Comparison: Week 5p-value: 0.4872Chi-square or Fisher exact

Comparison: Week 5p-value: 0.4634Chi-square or Fisher exact

Comparison: Week 7p-value: 0.605Chi-square or Fisher exact

Comparison: Week 7p-value: 0.4762Chi-square or Fisher exact

Comparison: Week 9p-value: >0.9999Chi-square or Fisher exact

Comparison: Week 12p-value: 0.4227Chi-square or Fisher exact

Comparison: Week 12p-value: 0.6796Chi-square or Fisher exact

Comparison: Week 16p-value: 0.4642Chi-square or Fisher exact

Comparison: Week 16p-value: 0.4645Chi-square or Fisher exact

Comparison: Week 20p-value: 0.2744Chi-square or Fisher exact

Comparison: Week 20p-value: 0.7026Chi-square or Fisher exact

Comparison: Week 24p-value: 0.7817Chi-square or Fisher exact

Comparison: Week 24p-value: 0.9285Chi-square or Fisher exact

Comparison: Week 38p-value: 0.0135Chi-square or Fisher exact

Comparison: Week 38p-value: 0.6992Chi-square or Fisher exact

Comparison: Week 52p-value: 0.0135Chi-square or Fisher exact

Comparison: Week 52p-value: 0.5154Chi-square or Fisher exact

Secondary

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

Time frame: Baseline to Week 52

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

Comparison: Week 3p-value: 0.0093Chi-square or Fisher exact

Comparison: Week 3p-value: >0.9999Chi-square or Fisher exact

Comparison: Week 5p-value: 0.0006Chi-square or Fisher exact

Comparison: Week 5p-value: 0.3449Chi-square or Fisher exact

Comparison: Week 7p-value: 0.0028Chi-square or Fisher exact

Comparison: Week 9p-value: 0.0001Chi-square or Fisher exact

Comparison: Week 9p-value: 0.0028Chi-square or Fisher exact

Comparison: Week 12p-value: <0.0001Chi-square or Fisher exact

Comparison: Week 12p-value: 0.0028Chi-square or Fisher exact

Comparison: Week 16p-value: <0.0001Chi-square or Fisher exact

Comparison: Week 16p-value: 0.0011Chi-square or Fisher exact

Comparison: Week 20p-value: 0.0094Chi-square or Fisher exact

Comparison: Week 20p-value: 0.1281Chi-square or Fisher exact

Comparison: Week 24p-value: 0.0051Chi-square or Fisher exact

Comparison: Week 24p-value: 0.1313Chi-square or Fisher exact

Comparison: Week 38p-value: 0.0268Chi-square or Fisher exact

Comparison: Week 38p-value: 0.3652Chi-square or Fisher exact

Comparison: Week 52p-value: 0.1854Chi-square or Fisher exact

Comparison: Week 52p-value: >0.9999Chi-square or Fisher exact

Secondary

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

Time frame: Up to 52 Weeks

Arm	Measure	Value (MEDIAN)
K-321 QID	Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	141.0 Days
K-321 BID	Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	181.0 Days
Placebo	Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	273.0 Days

p-value: 0.1209Log Rank

p-value: 0.7116Log Rank

Secondary

Time to Achievement of no Corneal Oedema of Study Eye

Time frame: Baseline to Week 52

Population: Proportions of patients from the FAS who achieved no corneal edema of the study eye

Arm	Measure	Value (MEDIAN)
K-321 QID	Time to Achievement of no Corneal Oedema of Study Eye	35.0 Days
K-321 BID	Time to Achievement of no Corneal Oedema of Study Eye	51.5 Days
Placebo	Time to Achievement of no Corneal Oedema of Study Eye	267.0 Days

p-value: 0.0021Log Rank

p-value: 0.1696Log Rank

Secondary

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

Time frame: Baseline up to Week 52

Arm	Measure	Value (MEDIAN)
K-321 QID	Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	50 Days
K-321 BID	Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	50.0 Days
Placebo	Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	165.0 Days

p-value: 0.0259Wilcoxon Rank Sum Test

p-value: 0.0068Wilcoxon Rank Sum Test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Central Corneal Endothelial Cell Density (ECD) at Week 12

Central Corneal ECD From Baseline to Each Subsequent Visit

Change From Baseline in Central Corneal Thickness

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

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

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

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

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

Time to Achievement of no Corneal Oedema of Study Eye

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