Trial Outcomes & Findings for Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT05913232)
NCT ID: NCT05913232
Last Updated: 2025-08-27
Results Overview
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Day 28
Results posted on
2025-08-27
Participant Flow
A 49-day screening period (screening visit plus washout period) occurred prior to randomization and the treatment period.
Participant milestones
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
50
|
49
|
|
Overall Study
COMPLETED
|
51
|
49
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
n=51 Participants
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
n=51 Participants
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
n=50 Participants
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
n=49 Participants
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
92 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
109 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
97 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
104 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
172 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
59 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
139 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Iris Color
Brown
|
30 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
122 Participants
n=36 Participants
|
|
Iris Color
Blue
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
|
Iris Color
Green
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Iris Color
Hazel
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Iris Color
Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Intent-to-Treat (ITT) is defined as all randomized subjects.
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
Outcome measures
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
n=51 study eyes
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
n=51 study eyes
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
n=50 study eyes
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
n=49 study eyes
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: Pre T0, change from baseline (mmHg)
|
-6.3 mmHg
Standard Deviation 3.27
|
-6.3 mmHg
Standard Deviation 3.15
|
-5.9 mmHg
Standard Deviation 3.45
|
-7.0 mmHg
Standard Deviation 3.26
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: T0 + 2h, change from baseline (mmHg)
|
-7.3 mmHg
Standard Deviation 3.07
|
-7.2 mmHg
Standard Deviation 3.14
|
-6.5 mmHg
Standard Deviation 3.67
|
-6.3 mmHg
Standard Deviation 3.83
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: T0 + 4h, change from baseline (mmHg)
|
-7.5 mmHg
Standard Deviation 3.28
|
-7.3 mmHg
Standard Deviation 3.24
|
-6.8 mmHg
Standard Deviation 3.48
|
-5.3 mmHg
Standard Deviation 3.53
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: T0 + 8h, change from baseline (mmHg)
|
-6.8 mmHg
Standard Deviation 3.67
|
-6.5 mmHg
Standard Deviation 3.50
|
-6.1 mmHg
Standard Deviation 3.12
|
-5.3 mmHg
Standard Deviation 3.21
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: T0 + 12h, change from baseline (mmHg)
|
-5.6 mmHg
Standard Deviation 3.82
|
-5.3 mmHg
Standard Deviation 3.37
|
-5.5 mmHg
Standard Deviation 3.44
|
-4.9 mmHg
Standard Deviation 3.35
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: 8-hour diurnal, change from baseline (mmHg)
|
-7.2 mmHg
Standard Deviation 3.04
|
-7.0 mmHg
Standard Deviation 2.90
|
-6.4 mmHg
Standard Deviation 3.14
|
-5.6 mmHg
Standard Deviation 3.16
|
|
Efficacy as Assessed by Change in Intraocular Pressure
Day 28: 12-hour diurnal, change from baseline (mmHg)
|
-6.8 mmHg
Standard Deviation 3.02
|
-6.6 mmHg
Standard Deviation 2.76
|
-6.2 mmHg
Standard Deviation 3.11
|
-5.4 mmHg
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 7, Day 14, and Day 28Population: Intent-to-Treat (ITT) is defined as all randomized subjects.
Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Outcome measures
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
n=51 study eyes
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
n=51 study eyes
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
n=50 study eyes
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
n=49 study eyes
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: T0 + 2h
|
66.7 percentage of subjects
Interval 52.1 to 79.2
|
63.3 percentage of subjects
Interval 48.3 to 76.6
|
55.1 percentage of subjects
Interval 40.2 to 69.3
|
58.3 percentage of subjects
Interval 43.2 to 72.4
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: T0 + 4h
|
74.5 percentage of subjects
Interval 60.4 to 85.7
|
81.6 percentage of subjects
Interval 68.0 to 91.2
|
79.6 percentage of subjects
Interval 65.7 to 89.8
|
52.1 percentage of subjects
Interval 37.2 to 66.7
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: T0 + 8h
|
68.6 percentage of subjects
Interval 54.1 to 80.9
|
77.6 percentage of subjects
Interval 63.4 to 88.2
|
67.3 percentage of subjects
Interval 52.5 to 80.1
|
62.5 percentage of subjects
Interval 47.4 to 76.0
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: Pre T0
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
0.0 percentage of subjects
Interval 0.0 to 7.1
|
0.0 percentage of subjects
Interval 0.0 to 7.3
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: T0 + 2h
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
3.9 percentage of subjects
Interval 0.5 to 13.5
|
4.0 percentage of subjects
Interval 0.5 to 13.7
|
2.0 percentage of subjects
Interval 0.1 to 10.9
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: T0 + 4h
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
2.0 percentage of subjects
Interval 0.1 to 10.6
|
2.0 percentage of subjects
Interval 0.1 to 10.9
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: T0 + 8h
|
5.9 percentage of subjects
Interval 1.2 to 16.2
|
3.9 percentage of subjects
Interval 0.5 to 13.5
|
6.0 percentage of subjects
Interval 1.3 to 16.5
|
6.1 percentage of subjects
Interval 1.3 to 16.9
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: T0 + 12h
|
10.9 percentage of subjects
Interval 3.6 to 23.6
|
10.9 percentage of subjects
Interval 3.6 to 23.6
|
15.2 percentage of subjects
Interval 6.3 to 28.9
|
13.3 percentage of subjects
Interval 5.1 to 26.8
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: 12-hour diurnal
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
2.0 percentage of subjects
Interval 0.1 to 10.6
|
2.0 percentage of subjects
Interval 0.1 to 10.9
|
|
Efficacy as Assessed by Intraocular Pressure
Day 0: 8-hour diurnal
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
2.0 percentage of subjects
Interval 0.1 to 10.6
|
2.0 percentage of subjects
Interval 0.1 to 10.9
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: Pre T0
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
0.0 percentage of subjects
Interval 0.0 to 7.1
|
0.0 percentage of subjects
Interval 0.0 to 7.3
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: T0 + 2h
|
31.4 percentage of subjects
Interval 19.1 to 45.9
|
35.3 percentage of subjects
Interval 22.4 to 49.9
|
28.0 percentage of subjects
Interval 16.2 to 42.5
|
46.9 percentage of subjects
Interval 32.5 to 61.7
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: T0 + 4h
|
51.0 percentage of subjects
Interval 36.6 to 65.2
|
58.8 percentage of subjects
Interval 44.2 to 72.4
|
70.0 percentage of subjects
Interval 55.4 to 82.1
|
63.3 percentage of subjects
Interval 48.3 to 76.6
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: T0 + 8h
|
60.8 percentage of subjects
Interval 46.1 to 74.2
|
68.6 percentage of subjects
Interval 54.1 to 80.9
|
74.0 percentage of subjects
Interval 59.7 to 85.4
|
61.2 percentage of subjects
Interval 46.2 to 74.8
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: T0 + 12h
|
67.4 percentage of subjects
Interval 52.0 to 80.5
|
72.3 percentage of subjects
Interval 57.4 to 84.4
|
84.4 percentage of subjects
Interval 70.5 to 93.5
|
76.1 percentage of subjects
Interval 61.2 to 87.4
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: 12-hour diurnal
|
54.9 percentage of subjects
Interval 40.3 to 68.9
|
54.9 percentage of subjects
Interval 40.3 to 68.9
|
52.0 percentage of subjects
Interval 37.4 to 66.3
|
53.1 percentage of subjects
Interval 38.3 to 67.5
|
|
Efficacy as Assessed by Intraocular Pressure
Day 1: 8-hour diurnal
|
47.1 percentage of subjects
Interval 32.9 to 61.5
|
51.0 percentage of subjects
Interval 36.6 to 65.2
|
52.0 percentage of subjects
Interval 37.4 to 66.3
|
53.1 percentage of subjects
Interval 38.3 to 67.5
|
|
Efficacy as Assessed by Intraocular Pressure
Day 7: Pre T0
|
37.3 percentage of subjects
Interval 24.1 to 51.9
|
30.0 percentage of subjects
Interval 17.9 to 44.6
|
20.4 percentage of subjects
Interval 10.2 to 34.3
|
44.9 percentage of subjects
Interval 30.7 to 59.8
|
|
Efficacy as Assessed by Intraocular Pressure
Day 14: Pre T0
|
41.2 percentage of subjects
Interval 27.6 to 55.8
|
36.0 percentage of subjects
Interval 22.9 to 50.8
|
26.5 percentage of subjects
Interval 14.9 to 41.1
|
47.9 percentage of subjects
Interval 33.3 to 62.8
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: Pre T0
|
31.4 percentage of subjects
Interval 19.1 to 45.9
|
40.0 percentage of subjects
Interval 26.4 to 54.8
|
34.7 percentage of subjects
Interval 21.7 to 49.6
|
52.1 percentage of subjects
Interval 37.2 to 66.7
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: T0 + 12h
|
67.4 percentage of subjects
Interval 52.0 to 80.5
|
68.9 percentage of subjects
Interval 53.4 to 81.8
|
71.1 percentage of subjects
Interval 55.7 to 83.6
|
64.4 percentage of subjects
Interval 48.8 to 78.1
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: 12-hour diurnal
|
58.8 percentage of subjects
Interval 44.2 to 72.4
|
63.3 percentage of subjects
Interval 48.3 to 76.6
|
65.3 percentage of subjects
Interval 50.4 to 78.3
|
54.2 percentage of subjects
Interval 39.2 to 68.6
|
|
Efficacy as Assessed by Intraocular Pressure
Day 28: 8-hour diurnal
|
64.7 percentage of subjects
Interval 50.1 to 77.6
|
67.3 percentage of subjects
Interval 52.5 to 80.1
|
65.3 percentage of subjects
Interval 50.4 to 78.3
|
50.0 percentage of subjects
Interval 35.2 to 64.8
|
SECONDARY outcome
Timeframe: Screening through Day 28Population: Safety population is defined as all randomized subjects who received at least one dose of investigational product.
Percentage of participants with ocular and systemic adverse events
Outcome measures
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
n=51 Participants
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
n=51 Participants
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
n=50 Participants
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
n=49 Participants
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Safety as Assessed by Adverse Event Reporting
Ocular Treatment-Emergent Adverse Events
|
43.1 percentage of subjects
Interval 29.3 to 57.8
|
60.8 percentage of subjects
Interval 46.1 to 74.2
|
64.0 percentage of subjects
Interval 49.2 to 77.1
|
18.4 percentage of subjects
Interval 8.8 to 32.0
|
|
Safety as Assessed by Adverse Event Reporting
Systemic Treatment-Emergent Adverse Events
|
3.9 percentage of subjects
Interval 0.5 to 13.5
|
7.8 percentage of subjects
Interval 2.2 to 18.9
|
4.0 percentage of subjects
Interval 0.5 to 13.7
|
2.0 percentage of subjects
Interval 0.1 to 10.9
|
Adverse Events
H-1337 0.6% Ophthalmic Solution b.i.d.
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
H-1337 1.0% Ophthalmic Solution b.i.d.
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Timolol 0.5% Ophthalmic Solution b.i.d.
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
H-1337 0.6% Ophthalmic Solution b.i.d.
n=51 participants at risk
One drop H-1337 twice daily in the study eye for 28 days
H-1337 0.6%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution b.i.d.
n=51 participants at risk
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
|
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
n=50 participants at risk
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
H-1337 Placebo: ophthalmic solution
|
Timolol 0.5% Ophthalmic Solution b.i.d.
n=49 participants at risk
One drop Timolol twice daily in the study eye for 28 days
Timolol 0.5%: ophthalmic solution
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
31.4%
16/51 • Number of events 25 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
37.3%
19/51 • Number of events 30 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
52.0%
26/50 • Number of events 44 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
10.2%
5/49 • Number of events 6 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
|
General disorders
Instillation site irritation
|
13.7%
7/51 • Number of events 7 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
21.6%
11/51 • Number of events 11 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
14.0%
7/50 • Number of events 7 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
6.1%
3/49 • Number of events 3 • 28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity. An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
|
Additional Information
Shigenobu Nakazora
D. Western Therapeutics Institute, Inc.
Phone: +81-52-218-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place