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Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery (NCT NCT05528172)

NCT ID: NCT05528172

Last Updated: 2026-08-06

Results Overview

Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

330 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2026-08-06

Participant Flow

Prior to assignment to treatment groups, participants provided informed consent and underwent preliminary screening to determine eligibility. Following preliminary confirmation, participants who were determined to be eligible after having cataract surgery, were assigned to one of four treatment groups.

Participant milestones

Participant milestones
Measure
K-321 4-Week Follow-Up (Group A)
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Placebo 14-Week Follow-Up (Group D)
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Overall Study
STARTED
145
80
70
35
Overall Study
COMPLETED
127
75
65
33
Overall Study
NOT COMPLETED
18
5
5
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Total
n=328 Participants
Total of all reporting groups
Race/Ethnicity, Customized
Other
2 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
0 Participants
n=6 Participants
4 Participants
n=7 Participants
Race/Ethnicity, Customized
Multiple
2 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
2 Participants
n=7 Participants
Age, Categorical
<=18 years
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=20 Participants
21 Participants
n=20 Participants
17 Participants
n=40 Participants
11 Participants
n=6 Participants
87 Participants
n=7 Participants
Age, Categorical
>=65 years
106 Participants
n=20 Participants
59 Participants
n=20 Participants
52 Participants
n=40 Participants
24 Participants
n=6 Participants
241 Participants
n=7 Participants
Sex: Female, Male
Female
78 Participants
n=20 Participants
50 Participants
n=20 Participants
42 Participants
n=40 Participants
15 Participants
n=6 Participants
185 Participants
n=7 Participants
Sex: Female, Male
Male
66 Participants
n=20 Participants
30 Participants
n=20 Participants
27 Participants
n=40 Participants
20 Participants
n=6 Participants
143 Participants
n=7 Participants
Race/Ethnicity, Customized
White
124 Participants
n=20 Participants
64 Participants
n=20 Participants
56 Participants
n=40 Participants
32 Participants
n=6 Participants
276 Participants
n=7 Participants
Race/Ethnicity, Customized
Black or African American
15 Participants
n=20 Participants
11 Participants
n=20 Participants
8 Participants
n=40 Participants
2 Participants
n=6 Participants
36 Participants
n=7 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
1 Participants
n=40 Participants
0 Participants
n=6 Participants
1 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=20 Participants
4 Participants
n=20 Participants
3 Participants
n=40 Participants
1 Participants
n=6 Participants
9 Participants
n=7 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Central corneal ECD was assessed at selected sites only; thus, the analysis population is a subset of the Full Analysis Set (FAS) from those sites.

Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=123 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=63 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12
—
-332.92 cells/mm2
Standard Deviation 479.887
-353.86 cells/mm2
Standard Deviation 542.459
—
—
—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Corneal ECD was assessed at selected sites only; thus, the analysis population is a subset of the Full Analysis Set (FAS) from those sites. The number analyzed at each time point varies due to missed visits or ungradable measurements due to any medical reason (e.g., corneal edema) and includes only participants with evaluable ECD data.

Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=19 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=123 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=62 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=85 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=43 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=38 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Central Corneal ECD at Each Visit
Week 3
-287.19 cells/mm2
Standard Deviation 487.558
-330.21 cells/mm2
Standard Deviation 485.405
-302.55 cells/mm2
Standard Deviation 424.972
-310.13 cells/mm2
Standard Deviation 489.885
-309.64 cells/mm2
Standard Deviation 399.551
-380.10 cells/mm2
Standard Deviation 477.826
Change From Baseline in Central Corneal ECD at Each Visit
Week 7
-289.21 cells/mm2
Standard Deviation 435.911
-329.08 cells/mm2
Standard Deviation 426.953
-292.98 cells/mm2
Standard Deviation 399.864
-310.04 cells/mm2
Standard Deviation 435.316
-294.72 cells/mm2
Standard Deviation 388.087
-370.32 cells/mm2
Standard Deviation 411.188
Change From Baseline in Central Corneal ECD at Each Visit
Week 12
-285.36 cells/mm2
Standard Deviation 413.454
-291.64 cells/mm2
Standard Deviation 408.500
-277.65 cells/mm2
Standard Deviation 376.183
-249.38 cells/mm2
Standard Deviation 405.794
-273.69 cells/mm2
Standard Deviation 361.818
-377.36 cells/mm2
Standard Deviation 406.232
Change From Baseline in Central Corneal ECD at Each Visit
Week 16
—
—
—
-262.98 cells/mm2
Standard Deviation 411.301
-273.38 cells/mm2
Standard Deviation 353.702
—
Change From Baseline in Central Corneal ECD at Each Visit
Week 26
-304.08 cells/mm2
Standard Deviation 387.713
—
—
—
—
-352.54 cells/mm2
Standard Deviation 347.875
Change From Baseline in Central Corneal ECD at Each Visit
Week 2
-340.68 cells/mm2
Standard Deviation 523.090
-327.21 cells/mm2
Standard Deviation 486.224
-330.14 cells/mm2
Standard Deviation 441.754
-292.98 cells/mm2
Standard Deviation 484.600
-325.92 cells/mm2
Standard Deviation 412.193
-399.46 cells/mm2
Standard Deviation 488.503
Change From Baseline in Central Corneal ECD at Each Visit
Day 1
-64.93 cells/mm2
Standard Deviation 100.596
-88.84 cells/mm2
Standard Deviation 163.330
-105.43 cells/mm2
Standard Deviation 137.037
-85.47 cells/mm2
Standard Deviation 154.233
-124.49 cells/mm2
Standard Deviation 148.710
-96.59 cells/mm2
Standard Deviation 185.153
Change From Baseline in Central Corneal ECD at Each Visit
Week 1
-322.39 cells/mm2
Standard Deviation 573.080
-322.02 cells/mm2
Standard Deviation 499.267
-280.71 cells/mm2
Standard Deviation 440.841
-284.40 cells/mm2
Standard Deviation 487.714
-263.42 cells/mm2
Standard Deviation 380.162
-399.35 cells/mm2
Standard Deviation 520.603

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: * Corneal ECD was assessed at selected sites only; thus, the analysis population is a subset of the Full Analysis Set (FAS) from those sites. * The number analyzed at each time point varies due to missed visits or ungradable measurements due to any medical reason (e.g., corneal edema) and includes only participants with evaluable ECD data.

Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=18 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=117 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=60 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=83 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=42 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=34 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Peripheral Corneal ECD (Nasal)
Day 1
-90.21 cells/mm2
Standard Deviation 168.626
-81.11 cells/mm2
Standard Deviation 153.865
-92.21 cells/mm2
Standard Deviation 195.890
-78.75 cells/mm2
Standard Deviation 139.318
-93.12 cells/mm2
Standard Deviation 209.483
-87.16 cells/mm2
Standard Deviation 188.981
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 1
-162.06 cells/mm2
Standard Deviation 311.927
-216.67 cells/mm2
Standard Deviation 409.958
-237.14 cells/mm2
Standard Deviation 377.480
-191.34 cells/mm2
Standard Deviation 387.939
-267.18 cells/mm2
Standard Deviation 400.360
-274.92 cells/mm2
Standard Deviation 458.279
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 7
-168.68 cells/mm2
Standard Deviation 264.297
-203.87 cells/mm2
Standard Deviation 355.794
-210.06 cells/mm2
Standard Deviation 315.957
-178.14 cells/mm2
Standard Deviation 329.071
-228.10 cells/mm2
Standard Deviation 337.605
-266.94 cells/mm2
Standard Deviation 413.250
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 12
-141.03 cells/mm2
Standard Deviation 247.570
-217.31 cells/mm2
Standard Deviation 372.450
-197.74 cells/mm2
Standard Deviation 293.136
-201.01 cells/mm2
Standard Deviation 362.525
-222.27 cells/mm2
Standard Deviation 310.698
-252.56 cells/mm2
Standard Deviation 396.881
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 2
-129.17 cells/mm2
Standard Deviation 192.528
-161.69 cells/mm2
Standard Deviation 322.973
-213.08 cells/mm2
Standard Deviation 347.780
-128.47 cells/mm2
Standard Deviation 266.769
-244.55 cells/mm2
Standard Deviation 387.866
-235.64 cells/mm2
Standard Deviation 418.007
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 3
-106.90 cells/mm2
Standard Deviation 151.397
-192.69 cells/mm2
Standard Deviation 344.401
-197.35 cells/mm2
Standard Deviation 328.513
-178.42 cells/mm2
Standard Deviation 331.729
-235.80 cells/mm2
Standard Deviation 374.804
-227.68 cells/mm2
Standard Deviation 377.100
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 16
—
—
—
-174.75 cells/mm2
Standard Deviation 325.123
-237.33 cells/mm2
Standard Deviation 272.756
—
Change From Baseline in Peripheral Corneal ECD (Nasal)
Week 26
-218.08 cells/mm2
Standard Deviation 244.792
—
—
—
—
-299.82 cells/mm2
Standard Deviation 374.591

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: * Corneal ECD was assessed at selected sites only; thus, the analysis population is a subset of the Full Analysis Set (FAS) from those sites. * The number analyzed at each time point varies due to missed visits and unevaluable measurements (e.g., ocular conditions such as corneal edema), and includes only participants with evaluable ECD data.

Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=18 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=121 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=61 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=85 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=43 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=36 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 3
-255.00 cells/mm2
Standard Deviation 380.029
-259.22 cells/mm2
Standard Deviation 416.084
-309.27 cells/mm2
Standard Deviation 401.608
-237.80 cells/mm2
Standard Deviation 398.882
-331.53 cells/mm2
Standard Deviation 412.847
-310.49 cells/mm2
Standard Deviation 457.017
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 7
-371.19 cells/mm2
Standard Deviation 488.609
-315.46 cells/mm2
Standard Deviation 431.471
-334.88 cells/mm2
Standard Deviation 441.341
-300.02 cells/mm2
Standard Deviation 430.888
-319.05 cells/mm2
Standard Deviation 424.914
-351.49 cells/mm2
Standard Deviation 437.339
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 26
-460.87 cells/mm2
Standard Deviation 513.357
—
—
—
—
-359.18 cells/mm2
Standard Deviation 386.891
Change From Baseline in Peripheral Corneal ECD (Temporal)
Day 1
-176.07 cells/mm2
Standard Deviation 352.524
-84.92 cells/mm2
Standard Deviation 197.209
-155.58 cells/mm2
Standard Deviation 249.007
-65.13 cells/mm2
Standard Deviation 186.469
-146.02 cells/mm2
Standard Deviation 189.556
-135.82 cells/mm2
Standard Deviation 217.799
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 1
-353.93 cells/mm2
Standard Deviation 665.696
-262.06 cells/mm2
Standard Deviation 499.732
-348.53 cells/mm2
Standard Deviation 526.676
-224.69 cells/mm2
Standard Deviation 471.737
-346.37 cells/mm2
Standard Deviation 469.818
-345.85 cells/mm2
Standard Deviation 555.975
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 2
-321.67 cells/mm2
Standard Deviation 475.389
-272.45 cells/mm2
Standard Deviation 478.927
-305.17 cells/mm2
Standard Deviation 439.810
-250.22 cells/mm2
Standard Deviation 483.818
-298.98 cells/mm2
Standard Deviation 431.926
-323.64 cells/mm2
Standard Deviation 470.772
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 12
-395.63 cells/mm2
Standard Deviation 499.033
-292.49 cells/mm2
Standard Deviation 398.082
-372.30 cells/mm2
Standard Deviation 457.659
-268.84 cells/mm2
Standard Deviation 393.356
-361.58 cells/mm2
Standard Deviation 444.188
-343.37 cells/mm2
Standard Deviation 409.504
Change From Baseline in Peripheral Corneal ECD (Temporal)
Week 16
—
—
—
-272.36 cells/mm2
Standard Deviation 354.950
-349.59 cells/mm2
Standard Deviation 393.670
—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The analysis population consisted of the Full Analysis Set (FAS). The number analyzed at each time point may vary due to missed visits, loss to follow-up, or missing or unevaluable data. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the analyzed datasets.

Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm)

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=212 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=114 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=143 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=79 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Central Corneal Thickness
Week 12
5.18 Micrometers (μm)
Standard Deviation 10.060
1.73 Micrometers (μm)
Standard Deviation 19.349
7.36 Micrometers (μm)
Standard Deviation 21.062
3.53 Micrometers (μm)
Standard Deviation 19.339
8.38 Micrometers (μm)
Standard Deviation 24.564
-1.86 Micrometers (μm)
Standard Deviation 19.011
Change From Baseline in Central Corneal Thickness
Week 16
—
—
—
5.32 Micrometers (μm)
Standard Deviation 17.783
3.79 Micrometers (μm)
Standard Deviation 20.911
—
Change From Baseline in Central Corneal Thickness
Week 26
5.59 Micrometers (μm)
Standard Deviation 12.134
—
—
—
—
2.23 Micrometers (μm)
Standard Deviation 25.269
Change From Baseline in Central Corneal Thickness
Week 3
12.38 Micrometers (μm)
Standard Deviation 18.629
6.78 Micrometers (μm)
Standard Deviation 23.291
22.18 Micrometers (μm)
Standard Deviation 27.433
8.31 Micrometers (μm)
Standard Deviation 25.387
26.31 Micrometers (μm)
Standard Deviation 29.529
3.56 Micrometers (μm)
Standard Deviation 17.854
Change From Baseline in Central Corneal Thickness
Week 7
9.64 Micrometers (μm)
Standard Deviation 14.108
2.28 Micrometers (μm)
Standard Deviation 21.836
12.23 Micrometers (μm)
Standard Deviation 27.313
3.71 Micrometers (μm)
Standard Deviation 22.988
13.37 Micrometers (μm)
Standard Deviation 31.448
-0.64 Micrometers (μm)
Standard Deviation 19.121
Change From Baseline in Central Corneal Thickness
Day 1
86.99 Micrometers (μm)
Standard Deviation 82.777
53.23 Micrometers (μm)
Standard Deviation 60.695
59.91 Micrometers (μm)
Standard Deviation 80.253
47.47 Micrometers (μm)
Standard Deviation 49.962
48.46 Micrometers (μm)
Standard Deviation 76.850
64.98 Micrometers (μm)
Standard Deviation 77.294
Change From Baseline in Central Corneal Thickness
Week 1
27.10 Micrometers (μm)
Standard Deviation 29.061
9.38 Micrometers (μm)
Standard Deviation 30.644
26.90 Micrometers (μm)
Standard Deviation 44.261
11.40 Micrometers (μm)
Standard Deviation 34.185
26.81 Micrometers (μm)
Standard Deviation 49.390
5.22 Micrometers (μm)
Standard Deviation 21.231
Change From Baseline in Central Corneal Thickness
Week 2
24.25 Micrometers (μm)
Standard Deviation 27.984
8.33 Micrometers (μm)
Standard Deviation 25.642
24.46 Micrometers (μm)
Standard Deviation 32.706
11.37 Micrometers (μm)
Standard Deviation 25.301
24.55 Micrometers (μm)
Standard Deviation 34.571
2.34 Micrometers (μm)
Standard Deviation 25.431

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The analysis population consisted of the Full Analysis Set (FAS). Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the analyzed datasets.

Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location.

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Number of Subjects With No Evidence of Corneal Edema
Screening (Visit 1)
34 Participants
213 Participants
114 Participants
144 Participants
80 Participants
69 Participants
Number of Subjects With No Evidence of Corneal Edema
Day 1
14 Participants
85 Participants
37 Participants
67 Participants
23 Participants
18 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 1
26 Participants
162 Participants
88 Participants
112 Participants
62 Participants
50 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 2
28 Participants
188 Participants
95 Participants
126 Participants
67 Participants
62 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 3
32 Participants
204 Participants
106 Participants
138 Participants
74 Participants
66 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 7
33 Participants
200 Participants
100 Participants
135 Participants
77 Participants
65 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 12
34 Participants
190 Participants
107 Participants
128 Participants
73 Participants
62 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 16
0 Participants
0 Participants
0 Participants
125 Participants
74 Participants
0 Participants
Number of Subjects With No Evidence of Corneal Edema
Week 26
33 Participants
0 Participants
0 Participants
0 Participants
0 Participants
65 Participants

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The analysis population consisted of the Full Analysis Set (FAS). Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the analyzed datasets.

Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Day 1
-2.1 Letters
Standard Deviation 22.21
6.4 Letters
Standard Deviation 17.07
3.0 Letters
Standard Deviation 20.39
6.9 Letters
Standard Deviation 17.48
5.2 Letters
Standard Deviation 19.27
5.5 Letters
Standard Deviation 16.29
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 1
12.6 Letters
Standard Deviation 15.51
13.0 Letters
Standard Deviation 14.61
12.9 Letters
Standard Deviation 18.47
12.8 Letters
Standard Deviation 14.58
13.0 Letters
Standard Deviation 19.69
13.4 Letters
Standard Deviation 14.77
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 2
14.2 Letters
Standard Deviation 13.87
14.1 Letters
Standard Deviation 14.02
13.8 Letters
Standard Deviation 17.60
13.8 Letters
Standard Deviation 13.69
13.7 Letters
Standard Deviation 18.98
14.7 Letters
Standard Deviation 14.75
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 3
13.4 Letters
Standard Deviation 13.40
15.0 Letters
Standard Deviation 15.59
15.1 Letters
Standard Deviation 17.49
15.4 Letters
Standard Deviation 15.76
15.9 Letters
Standard Deviation 19.05
14.2 Letters
Standard Deviation 15.31
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 12
14.3 Letters
Standard Deviation 12.77
14.0 Letters
Standard Deviation 13.23
15.0 Letters
Standard Deviation 16.07
14.2 Letters
Standard Deviation 13.41
15.4 Letters
Standard Deviation 17.45
13.7 Letters
Standard Deviation 12.96
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 16
—
—
—
14.8 Letters
Standard Deviation 13.23
14.9 Letters
Standard Deviation 16.82
—
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 26
14.8 Letters
Standard Deviation 12.64
—
—
—
—
13.8 Letters
Standard Deviation 13.66
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Week 7
13.4 Letters
Standard Deviation 13.46
14.5 Letters
Standard Deviation 15.32
15.1 Letters
Standard Deviation 17.22
14.8 Letters
Standard Deviation 15.31
15.8 Letters
Standard Deviation 18.66
13.7 Letters
Standard Deviation 15.44

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The analysis population consisted of the Full Analysis Set (FAS). The number analyzed at each time point may vary due to missed visits, loss to follow-up, or missing or unevaluable data. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the analyzed datasets.

Visual Function assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), a patient-reported measure of vision-related functioning and quality of life. Scores range from 0 to 100, with higher scores indicating better visual function and lower scores indicating worse visual function. The total composite score is derived from multiple subscales using the standard VFQ-25 scoring method.

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in VFQ-25 (Overall)
Week 3
12.13 Score on a Scale
Standard Deviation 15.731
13.79 Score on a Scale
Standard Deviation 15.729
9.95 Score on a Scale
Standard Deviation 15.206
14.01 Score on a Scale
Standard Deviation 16.619
8.98 Score on a Scale
Standard Deviation 14.971
13.34 Score on a Scale
Standard Deviation 13.806
Change From Baseline in VFQ-25 (Overall)
Week 12
12.40 Score on a Scale
Standard Deviation 17.993
16.12 Score on a Scale
Standard Deviation 14.361
12.38 Score on a Scale
Standard Deviation 16.158
16.61 Score on a Scale
Standard Deviation 14.851
12.37 Score on a Scale
Standard Deviation 15.373
15.16 Score on a Scale
Standard Deviation 13.389
Change From Baseline in VFQ-25 (Overall)
Week 16
—
—
—
18.18 Score on a Scale
Standard Deviation 15.373
12.87 Score on a Scale
Standard Deviation 14.379
—
Change From Baseline in VFQ-25 (Overall)
Week 26
15.28 Score on a Scale
Standard Deviation 16.112
—
—
—
—
16.00 Score on a Scale
Standard Deviation 14.054

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the Analysis Set.

Shift in slit-lamp biomicroscopy findings of the study eye categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. \- Baseline to Post-Baseline Shift

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Normal - Normal
26 Participants
162 Participants
86 Participants
110 Participants
60 Participants
52 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Normal - Abnormal, not clinically significant (NCS)
4 Participants
15 Participants
9 Participants
9 Participants
5 Participants
6 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Normal - Abnormal, clinically significant (CS)
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, NCS - Normal
2 Participants
8 Participants
6 Participants
6 Participants
4 Participants
2 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, NCS - Abnormal, NCS
2 Participants
8 Participants
6 Participants
4 Participants
4 Participants
4 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, NCS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, CS - Normal
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, CS - Abnormal, NCS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 12 · Abnormal, CS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Normal - Normal
—
—
—
110 Participants
64 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Normal - Abnormal, not clinically significant (NCS)
—
—
—
6 Participants
3 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Normal - Abnormal, clinically significant (CS)
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, NCS - Normal
—
—
—
5 Participants
3 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, NCS - Abnormal, NCS
—
—
—
4 Participants
4 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, NCS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, CS - Normal
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, CS - Abnormal, NCS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 16 · Abnormal, CS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Normal - Normal
29 Participants
—
—
—
—
55 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Normal - Abnormal, not clinically significant (NCS)
1 Participants
—
—
—
—
4 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Normal - Abnormal, clinically significant (CS)
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, NCS - Normal
1 Participants
—
—
—
—
3 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, NCS - Abnormal, NCS
2 Participants
—
—
—
—
3 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, NCS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, CS - Normal
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, CS - Abnormal, NCS
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Week 26 · Abnormal, CS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the Analysis Set.

Shift in slit-lamp biomicroscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Normal - Normal
19 Participants
133 Participants
67 Participants
92 Participants
48 Participants
41 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Normal - Abnormal, NCS
1 Participants
13 Participants
4 Participants
8 Participants
3 Participants
5 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Normal - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, NCS - Normal
3 Participants
13 Participants
8 Participants
7 Participants
5 Participants
6 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, NCS - Abnormal, NCS
10 Participants
34 Participants
28 Participants
22 Participants
18 Participants
12 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, NCS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, CS - Normal
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, CS - Abnormal, NCS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 12 · Abnormal, CS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Normal - Normal
—
—
—
87 Participants
46 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Normal - Abnormal, NCS
—
—
—
11 Participants
5 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Normal - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, NCS - Normal
—
—
—
8 Participants
7 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, NCS - Abnormal, NCS
—
—
—
19 Participants
16 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, NCS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, CS - Normal
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, CS - Abnormal, NCS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 16 · Abnormal, CS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Normal - Normal
19 Participants
—
—
—
—
43 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Normal - Abnormal, NCS
0 Participants
—
—
—
—
4 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Normal - Abnormal, CS
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, NCS - Normal
2 Participants
—
—
—
—
6 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, NCS - Abnormal, NCS
11 Participants
—
—
—
—
12 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, NCS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, CS - Normal
1 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, CS - Abnormal, NCS
0 Participants
—
—
—
—
0 Participants
Shifts in Slit-lamp Biomicroscopy (Cornea)
Week 26 · Abnormal, CS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the Analysis Set.

Shift in dilated fundoscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Normal - Normal
33 Participants
178 Participants
106 Participants
120 Participants
73 Participants
58 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Normal - Abnormal, NCS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Normal - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, NCS - Normal
0 Participants
6 Participants
0 Participants
3 Participants
0 Participants
3 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, NCS - Abnormal, NCS
0 Participants
8 Participants
1 Participants
5 Participants
1 Participants
3 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, NCS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, CS - Normal
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, CS - Abnormal, NCS
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 12 · Abnormal, CS - Abnormal, CS
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Normal - Normal
—
—
—
118 Participants
73 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Normal - Abnormal, NCS
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Normal - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, NCS - Normal
—
—
—
4 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, NCS - Abnormal, NCS
—
—
—
3 Participants
1 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, NCS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, CS - Normal
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, CS - Abnormal, NCS
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 16 · Abnormal, CS - Abnormal, CS
—
—
—
0 Participants
0 Participants
—
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Normal - Normal
32 Participants
—
—
—
—
57 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Normal - Abnormal, NCS
0 Participants
—
—
—
—
2 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Normal - Abnormal, CS
0 Participants
—
—
—
—
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, NCS - Normal
0 Participants
—
—
—
—
3 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, NCS - Abnormal, NCS
0 Participants
—
—
—
—
3 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, NCS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, CS - Normal
1 Participants
—
—
—
—
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, CS - Abnormal, NCS
0 Participants
—
—
—
—
0 Participants
Shifts in Dilated Fundoscopy (Central Retina)
Week 26 · Abnormal, CS - Abnormal, CS
0 Participants
—
—
—
—
0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: The Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug. Two participants randomized to the K-321 group withdrew before receiving study drug and were not included in the Analysis Set.

Intraocular pressure (IOP) of the study eye, measured using either a contact or non-contact tonometer, and recorded in millimeters of mercury (mm Hg).

Outcome measures

Outcome measures
Measure
Placebo 14-Week Follow-Up (Group D)
n=35 Participants
Placebo QID for 12 weeks followed by a 14-week follow-up period with no treatment.
All Subjects: K-321
n=213 Participants
All subjects receiving K-321 QID for up to 12 Weeks
All Subjects: Placebo
n=115 Participants
All subjects receiving Placebo QID for up to 12 Weeks
K-321 4-Week Follow-Up (Group A)
n=144 Participants
K-321 QID for 12 weeks followed by a 4-week follow-up period with no treatment.
Placebo 4-Week Follow-Up (Group C)
n=80 Participants
Placebo QID for 12 weeks followed by a 4-week follow-up period with no treatment.
K-321 14-Week Follow-Up (Group B)
n=69 Participants
K-321 QID for 12 weeks followed by a 14-week follow-up period with no treatment.
Change From Baseline in Intraocular Pressure (mmHg)
Week 3
-1.4 mmHg
Standard Deviation 3.02
-1.4 mmHg
Standard Deviation 3.39
-0.7 mmHg
Standard Deviation 3.15
-1.2 mmHg
Standard Deviation 3.45
-0.4 mmHg
Standard Deviation 3.18
-1.8 mmHg
Standard Deviation 3.24
Change From Baseline in Intraocular Pressure (mmHg)
Week 7
-2.1 mmHg
Standard Deviation 2.56
-1.8 mmHg
Standard Deviation 3.42
-1.7 mmHg
Standard Deviation 2.78
-1.7 mmHg
Standard Deviation 3.64
-1.5 mmHg
Standard Deviation 2.87
-1.9 mmHg
Standard Deviation 2.94
Change From Baseline in Intraocular Pressure (mmHg)
Week 12
-2.1 mmHg
Standard Deviation 2.99
-1.9 mmHg
Standard Deviation 3.13
-1.7 mmHg
Standard Deviation 3.11
-1.9 mmHg
Standard Deviation 2.98
-1.5 mmHg
Standard Deviation 3.15
-2.0 mmHg
Standard Deviation 3.43
Change From Baseline in Intraocular Pressure (mmHg)
Week 16
—
—
—
-1.9 mmHg
Standard Deviation 3.15
-1.6 mmHg
Standard Deviation 3.01
—
Change From Baseline in Intraocular Pressure (mmHg)
Week 26
-2.6 mmHg
Standard Deviation 3.04
—
—
—
—
-2.4 mmHg
Standard Deviation 3.17
Change From Baseline in Intraocular Pressure (mmHg)
Week 2
-0.5 mmHg
Standard Deviation 2.68
-1.0 mmHg
Standard Deviation 3.24
-0.4 mmHg
Standard Deviation 3.02
-0.6 mmHg
Standard Deviation 3.30
-0.4 mmHg
Standard Deviation 3.16
-1.7 mmHg
Standard Deviation 3.03
Change From Baseline in Intraocular Pressure (mmHg)
Day 1
2.4 mmHg
Standard Deviation 5.04
2.8 mmHg
Standard Deviation 5.76
2.4 mmHg
Standard Deviation 4.83
3.0 mmHg
Standard Deviation 6.01
2.4 mmHg
Standard Deviation 4.76
2.2 mmHg
Standard Deviation 5.21
Change From Baseline in Intraocular Pressure (mmHg)
Week 1
0.1 mmHg
Standard Deviation 3.47
-0.8 mmHg
Standard Deviation 3.41
0.1 mmHg
Standard Deviation 3.47
-0.7 mmHg
Standard Deviation 3.27
0.1 mmHg
Standard Deviation 3.49
-1.1 mmHg
Standard Deviation 3.68

Adverse Events

K-321 12-Week Treatment (Group A and B)

Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths

Placebo 12-Week Treatment (Group C and D)

Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths

K-321 4-Week Follow-Up (Group A and B)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo 4-Week Follow-Up (Group C and D)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

K-321 4 to 14-Week Follow-Up (Group B)

Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths

Placebo 4 to 14-Week Follow-Up (Group D)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
K-321 12-Week Treatment (Group A and B)
n=213 participants at risk
All participants from the Safety Analysis Set who received K-321 through Week 12 (SP12). Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 12-Week Treatment (Group C and D)
n=115 participants at risk
All participants from the Safety Analysis Set who received Placebo through Week 12 (SP12). Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
K-321 4-Week Follow-Up (Group A and B)
n=201 participants at risk
All participants from the Safety Analysis Set who received K-321 and completed the 16-week (SP16) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 4-Week Follow-Up (Group C and D)
n=110 participants at risk
All participants from the Safety Analysis Set who received placebo and completed the 16-week (SP16) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
K-321 4 to 14-Week Follow-Up (Group B)
n=65 participants at risk
All participants from the Safety Analysis Set who received K-321 and completed the 26-week (SP26) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 4 to 14-Week Follow-Up (Group D)
n=34 participants at risk
All participants from the Safety Analysis Set who received placebo and completed the 26-week (SP26) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Eye disorders
Retinal detachment
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Cardiac disorders
Atrial fibrillation
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.91%
1/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Cardiac disorders
Ventricular tachycardia
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
1.5%
1/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Endocrine disorders
Hypoglycaemia
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Gastrointestinal disorders
Duodenal ulcer
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Gastrointestinal disorders
Peptic ulcer
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.50%
1/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Infections and infestations
Cellulitis
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.91%
1/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Infections and infestations
Gastroenteritis
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
1.5%
1/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Injury, poisoning and procedural complications
Road traffic accident
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Injury, poisoning and procedural complications
Spinal fracture
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.87%
1/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Renal and urinary disorders
Acute kidney injury
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
1.5%
1/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.87%
1/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
Vascular disorders
Hypotension
0.47%
1/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug

Other adverse events

Other adverse events
Measure
K-321 12-Week Treatment (Group A and B)
n=213 participants at risk
All participants from the Safety Analysis Set who received K-321 through Week 12 (SP12). Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 12-Week Treatment (Group C and D)
n=115 participants at risk
All participants from the Safety Analysis Set who received Placebo through Week 12 (SP12). Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
K-321 4-Week Follow-Up (Group A and B)
n=201 participants at risk
All participants from the Safety Analysis Set who received K-321 and completed the 16-week (SP16) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 4-Week Follow-Up (Group C and D)
n=110 participants at risk
All participants from the Safety Analysis Set who received placebo and completed the 16-week (SP16) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
K-321 4 to 14-Week Follow-Up (Group B)
n=65 participants at risk
All participants from the Safety Analysis Set who received K-321 and completed the 26-week (SP26) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Placebo 4 to 14-Week Follow-Up (Group D)
n=34 participants at risk
All participants from the Safety Analysis Set who received placebo and completed the 26-week (SP26) periods. Participants who withdrew or were lost to follow-up prior to the analysis window are not included.
Eye disorders
Posterior capsule opacification (Study Eye)
8.0%
17/213 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
9.6%
11/115 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
1.5%
3/201 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
2.7%
3/110 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
1.5%
1/65 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug
0.00%
0/34 • Baseline to Week 26
A TEAE was defined as an adverse event that began after the start of randomized study drug or an event that began before the start of the randomized study drug and worsened in severity after the start of the randomized study drug. Subjects experiencing TEAEs were counted according to the study period in which the event(s) occurred. One death occurred during the study, due to a motor vehicle accident; the death was not related to study drug

Additional Information

Director, Clinical Operations

Kowa Research Institute, Inc.

Phone: 1 (919) 433-1600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place