Trial Outcomes & Findings for A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study (NCT NCT03216902)
NCT ID: NCT03216902
Last Updated: 2020-10-23
Results Overview
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
241 participants
Primary outcome timeframe
9:00, 13:00 and 17:00 at Month 3
Results posted on
2020-10-23
Participant Flow
Participant milestones
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
44
|
43
|
43
|
44
|
45
|
|
Overall Study
COMPLETED
|
20
|
43
|
42
|
43
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Baseline characteristics by cohort
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 13.30 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.41 • n=4 Participants
|
61.0 years
STANDARD_DEVIATION 11.84 • n=21 Participants
|
63.8 years
STANDARD_DEVIATION 11.84 • n=8 Participants
|
63.6 years
STANDARD_DEVIATION 11.22 • n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
135 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
106 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
209 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
11 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
21 participants
n=21 Participants
|
21 participants
n=8 Participants
|
114 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
23 participants
n=4 Participants
|
23 participants
n=21 Participants
|
24 participants
n=8 Participants
|
127 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 9:00, 13:00 and 17:00 at Month 3Population: The number of participants is reduced due to missing data.
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Intraocular Pressure in the Study Eye at Month 3
9:00
|
18.8 mmHg
Standard Deviation 4.11
|
18.1 mmHg
Standard Deviation 3.73
|
19.7 mmHg
Standard Deviation 3.27
|
19.2 mmHg
Standard Deviation 3.37
|
17.6 mmHg
Standard Deviation 3.13
|
19.3 mmHg
Standard Deviation 2.92
|
|
Intraocular Pressure in the Study Eye at Month 3
13:00
|
17.6 mmHg
Standard Deviation 3.18
|
17.3 mmHg
Standard Deviation 3.01
|
18.5 mmHg
Standard Deviation 2.98
|
18.1 mmHg
Standard Deviation 2.99
|
17.4 mmHg
Standard Deviation 2.39
|
18.7 mmHg
Standard Deviation 3.17
|
|
Intraocular Pressure in the Study Eye at Month 3
17:00
|
17.8 mmHg
Standard Deviation 2.87
|
17.2 mmHg
Standard Deviation 3.10
|
18.3 mmHg
Standard Deviation 2.55
|
17.8 mmHg
Standard Deviation 2.93
|
16.7 mmHg
Standard Deviation 2.74
|
17.9 mmHg
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 9:00, 13:00 and 17:00 at Week 6Population: The number of participants is reduced due to missing data. This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=43 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=44 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=45 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Intraocular Pressure in the Study Eye at Week 6
9:00
|
23.2 mmHg
Standard Error 0.66
|
19.0 mmHg
Standard Error 0.46
|
18.5 mmHg
Standard Error 0.46
|
18.7 mmHg
Standard Error 0.45
|
18.7 mmHg
Standard Error 0.45
|
—
|
|
Intraocular Pressure in the Study Eye at Week 6
13:00
|
22.2 mmHg
Standard Error 0.61
|
18.2 mmHg
Standard Error 0.42
|
17.9 mmHg
Standard Error 0.42
|
17.3 mmHg
Standard Error 0.42
|
17.5 mmHg
Standard Error 0.41
|
—
|
|
Intraocular Pressure in the Study Eye at Week 6
17:00
|
21.6 mmHg
Standard Error 0.62
|
17.8 mmHg
Standard Error 0.43
|
17.9 mmHg
Standard Error 0.43
|
16.6 mmHg
Standard Error 0.42
|
17.4 mmHg
Standard Error 0.42
|
—
|
SECONDARY outcome
Timeframe: 9:00, 13:00 and 17:00 at Week 1 and Week 2Population: The number of participants is reduced due to missing data.
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week1 9:00
|
22.8 mmHg
Standard Deviation 3.99
|
17.7 mmHg
Standard Deviation 2.67
|
19.4 mmHg
Standard Deviation 3.32
|
18.9 mmHg
Standard Deviation 2.82
|
18.1 mmHg
Standard Deviation 2.99
|
18.0 mmHg
Standard Deviation 2.66
|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week1 13:00
|
22.8 mmHg
Standard Deviation 3.66
|
17.5 mmHg
Standard Deviation 2.25
|
18.7 mmHg
Standard Deviation 3.28
|
18.6 mmHg
Standard Deviation 3.29
|
17.1 mmHg
Standard Deviation 2.65
|
17.6 mmHg
Standard Deviation 3.08
|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week1 17:00
|
21.6 mmHg
Standard Deviation 3.94
|
17.4 mmHg
Standard Deviation 2.43
|
18.1 mmHg
Standard Deviation 2.94
|
18.5 mmHg
Standard Deviation 3.23
|
16.9 mmHg
Standard Deviation 2.96
|
17.2 mmHg
Standard Deviation 2.53
|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week 2 9:00
|
22.7 mmHg
Standard Deviation 3.70
|
17.6 mmHg
Standard Deviation 3.33
|
19.4 mmHg
Standard Deviation 3.62
|
18.7 mmHg
Standard Deviation 2.73
|
17.9 mmHg
Standard Deviation 3.11
|
18.3 mmHg
Standard Deviation 3.13
|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week 2 13:00
|
22.0 mmHg
Standard Deviation 3.13
|
17.4 mmHg
Standard Deviation 2.45
|
18.2 mmHg
Standard Deviation 2.93
|
18.1 mmHg
Standard Deviation 2.77
|
17.2 mmHg
Standard Deviation 2.57
|
17.6 mmHg
Standard Deviation 2.80
|
|
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Week2 17:00
|
21.9 mmHg
Standard Deviation 3.93
|
16.9 mmHg
Standard Deviation 2.49
|
18.2 mmHg
Standard Deviation 2.94
|
17.8 mmHg
Standard Deviation 2.33
|
16.7 mmHg
Standard Deviation 2.89
|
17.3 mmHg
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1
|
22.4 mmHg
Standard Deviation 3.48
|
17.5 mmHg
Standard Deviation 2.12
|
18.8 mmHg
Standard Deviation 2.95
|
18.7 mmHg
Standard Deviation 2.88
|
17.4 mmHg
Standard Deviation 2.64
|
17.6 mmHg
Standard Deviation 2.59
|
|
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 2
|
22.2 mmHg
Standard Deviation 3.33
|
17.3 mmHg
Standard Deviation 2.51
|
18.6 mmHg
Standard Deviation 2.92
|
18.2 mmHg
Standard Deviation 2.37
|
17.3 mmHg
Standard Deviation 2.58
|
17.7 mmHg
Standard Deviation 2.52
|
|
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 6
|
21.7 mmHg
Standard Deviation 2.90
|
17.3 mmHg
Standard Deviation 2.80
|
18.4 mmHg
Standard Deviation 2.40
|
18.1 mmHg
Standard Deviation 2.50
|
17.5 mmHg
Standard Deviation 2.69
|
17.8 mmHg
Standard Deviation 2.69
|
|
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Month 3
|
18.1 mmHg
Standard Deviation 3.14
|
17.5 mmHg
Standard Deviation 2.98
|
18.8 mmHg
Standard Deviation 2.66
|
18.4 mmHg
Standard Deviation 2.94
|
17.2 mmHg
Standard Deviation 2.47
|
18.6 mmHg
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1
|
-2.1 mmHg
Standard Deviation 2.13
|
-6.7 mmHg
Standard Deviation 2.98
|
-5.5 mmHg
Standard Deviation 2.41
|
-5.6 mmHg
Standard Deviation 2.84
|
-6.7 mmHg
Standard Deviation 3.19
|
-6.6 mmHg
Standard Deviation 2.92
|
|
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 2
|
-2.0 mmHg
Standard Deviation 2.15
|
-7.0 mmHg
Standard Deviation 3.13
|
-5.8 mmHg
Standard Deviation 3.02
|
-6.0 mmHg
Standard Deviation 2.35
|
-6.9 mmHg
Standard Deviation 2.87
|
-6.5 mmHg
Standard Deviation 2.94
|
|
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 6
|
-2.3 mmHg
Standard Deviation 2.49
|
-7.0 mmHg
Standard Deviation 3.09
|
-5.9 mmHg
Standard Deviation 2.73
|
-6.1 mmHg
Standard Deviation 2.59
|
-6.6 mmHg
Standard Deviation 3.08
|
-6.4 mmHg
Standard Deviation 2.68
|
|
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Month 3
|
-5.9 mmHg
Standard Deviation 2.65
|
-6.7 mmHg
Standard Deviation 3.24
|
-5.5 mmHg
Standard Deviation 2.11
|
-5.9 mmHg
Standard Deviation 2.71
|
-6.9 mmHg
Standard Deviation 2.96
|
-5.5 mmHg
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 1
|
-8.6 Percentage of change
Standard Deviation 8.15
|
-27.3 Percentage of change
Standard Deviation 10.60
|
-22.8 Percentage of change
Standard Deviation 9.59
|
-22.9 Percentage of change
Standard Deviation 10.78
|
-27.4 Percentage of change
Standard Deviation 11.48
|
-27.0 Percentage of change
Standard Deviation 11.12
|
|
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 2
|
-8.6 Percentage of change
Standard Deviation 8.74
|
-28.3 Percentage of change
Standard Deviation 11.05
|
-23.5 Percentage of change
Standard Deviation 11.28
|
-24.7 Percentage of change
Standard Deviation 8.90
|
-28.2 Percentage of change
Standard Deviation 10.48
|
-26.4 Percentage of change
Standard Deviation 11.27
|
|
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Week 6
|
-9.4 Percentage of change
Standard Deviation 10.31
|
-28.5 Percentage of change
Standard Deviation 11.23
|
-24.0 Percentage of change
Standard Deviation 9.58
|
-25.1 Percentage of change
Standard Deviation 9.83
|
-27.2 Percentage of change
Standard Deviation 10.72
|
-26.2 Percentage of change
Standard Deviation 10.51
|
|
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Month 3
|
-24.7 Percentage of change
Standard Deviation 11.26
|
-27.5 Percentage of change
Standard Deviation 12.11
|
-22.6 Percentage of change
Standard Deviation 8.22
|
-24.1 Percentage of change
Standard Deviation 10.45
|
-28.4 Percentage of change
Standard Deviation 10.54
|
-22.7 Percentage of change
Standard Deviation 10.79
|
SECONDARY outcome
Timeframe: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 13:00
|
-6.0 mmHg
Standard Deviation 3.28
|
-6.9 mmHg
Standard Deviation 3.25
|
-5.9 mmHg
Standard Deviation 2.49
|
-6.0 mmHg
Standard Deviation 2.97
|
-6.7 mmHg
Standard Deviation 3.34
|
-5.5 mmHg
Standard Deviation 3.53
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 9:00
|
-2.1 mmHg
Standard Deviation 2.68
|
-7.3 mmHg
Standard Deviation 3.65
|
-5.3 mmHg
Standard Deviation 2.65
|
-6.0 mmHg
Standard Deviation 3.10
|
-6.7 mmHg
Standard Deviation 3.70
|
-6.6 mmHg
Standard Deviation 3.24
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 13:00
|
-1.2 mmHg
Standard Deviation 2.73
|
-6.8 mmHg
Standard Deviation 3.35
|
-5.7 mmHg
Standard Deviation 2.73
|
-5.6 mmHg
Standard Deviation 3.26
|
-6.8 mmHg
Standard Deviation 3.59
|
-6.7 mmHg
Standard Deviation 3.63
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 17:00
|
-2.8 mmHg
Standard Deviation 2.81
|
-6.2 mmHg
Standard Deviation 3.33
|
-5.6 mmHg
Standard Deviation 2.83
|
-5.2 mmHg
Standard Deviation 3.62
|
-6.7 mmHg
Standard Deviation 3.60
|
-6.4 mmHg
Standard Deviation 2.98
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 9:00
|
-1.9 mmHg
Standard Deviation 2.66
|
-7.4 mmHg
Standard Deviation 4.03
|
-5.5 mmHg
Standard Deviation 3.52
|
-6.2 mmHg
Standard Deviation 3.00
|
-6.9 mmHg
Standard Deviation 3.32
|
-6.4 mmHg
Standard Deviation 3.66
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 13:00
|
-1.8 mmHg
Standard Deviation 2.89
|
-6.8 mmHg
Standard Deviation 3.02
|
-6.2 mmHg
Standard Deviation 3.36
|
-6.0 mmHg
Standard Deviation 2.62
|
-6.8 mmHg
Standard Deviation 3.27
|
-6.7 mmHg
Standard Deviation 3.22
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 17:00
|
-2.4 mmHg
Standard Deviation 2.57
|
-6.7 mmHg
Standard Deviation 3.39
|
-5.7 mmHg
Standard Deviation 3.36
|
-5.8 mmHg
Standard Deviation 2.52
|
-6.9 mmHg
Standard Deviation 3.29
|
-6.3 mmHg
Standard Deviation 3.15
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 9:00
|
-2.0 mmHg
Standard Deviation 2.59
|
-7.0 mmHg
Standard Deviation 3.84
|
-5.7 mmHg
Standard Deviation 3.03
|
-6.4 mmHg
Standard Deviation 2.83
|
-6.1 mmHg
Standard Deviation 3.21
|
-6.1 mmHg
Standard Deviation 3.55
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 13:00
|
-2.1 mmHg
Standard Deviation 2.66
|
-7.0 mmHg
Standard Deviation 3.30
|
-6.1 mmHg
Standard Deviation 3.65
|
-6.2 mmHg
Standard Deviation 2.64
|
-6.8 mmHg
Standard Deviation 3.67
|
-6.8 mmHg
Standard Deviation 3.11
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 17:00
|
-2.7 mmHg
Standard Deviation 3.33
|
-6.8 mmHg
Standard Deviation 3.38
|
-5.9 mmHg
Standard Deviation 2.56
|
-5.7 mmHg
Standard Deviation 3.30
|
-7.0 mmHg
Standard Deviation 3.36
|
-6.2 mmHg
Standard Deviation 3.16
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 9:00
|
-5.6 mmHg
Standard Deviation 3.21
|
-6.9 mmHg
Standard Deviation 3.84
|
-5.1 mmHg
Standard Deviation 2.42
|
-5.7 mmHg
Standard Deviation 3.08
|
-7.2 mmHg
Standard Deviation 3.32
|
-5.4 mmHg
Standard Deviation 3.41
|
|
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 17:00
|
-6.1 mmHg
Standard Deviation 2.74
|
-6.4 mmHg
Standard Deviation 3.63
|
-5.4 mmHg
Standard Deviation 2.74
|
-5.8 mmHg
Standard Deviation 3.12
|
-6.9 mmHg
Standard Deviation 3.48
|
-5.5 mmHg
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 17:00
|
-9.9 Percentage of change in IOP
Standard Deviation 10.16
|
-27.8 Percentage of change in IOP
Standard Deviation 12.69
|
-23.5 Percentage of change in IOP
Standard Deviation 12.42
|
-24.4 Percentage of change in IOP
Standard Deviation 9.53
|
-28.8 Percentage of change in IOP
Standard Deviation 12.48
|
-26.3 Percentage of change in IOP
Standard Deviation 11.95
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 9:00
|
-8.4 Percentage of change in IOP
Standard Deviation 10.71
|
-27.5 Percentage of change in IOP
Standard Deviation 12.44
|
-22.8 Percentage of change in IOP
Standard Deviation 10.71
|
-25.3 Percentage of change in IOP
Standard Deviation 9.93
|
-24.4 Percentage of change in IOP
Standard Deviation 11.45
|
-24.3 Percentage of change in IOP
Standard Deviation 13.78
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 13:00
|
-8.6 Percentage of change in IOP
Standard Deviation 10.89
|
-28.8 Percentage of change in IOP
Standard Deviation 12.25
|
-24.5 Percentage of change in IOP
Standard Deviation 12.69
|
-25.6 Percentage of change in IOP
Standard Deviation 9.85
|
-27.7 Percentage of change in IOP
Standard Deviation 12.16
|
-27.8 Percentage of change in IOP
Standard Deviation 11.27
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 9:00
|
-8.7 Percentage of change in IOP
Standard Deviation 9.58
|
-28.5 Percentage of change in IOP
Standard Deviation 12.00
|
-21.6 Percentage of change in IOP
Standard Deviation 10.44
|
-23.7 Percentage of change in IOP
Standard Deviation 11.01
|
-26.5 Percentage of change in IOP
Standard Deviation 12.64
|
-26.5 Percentage of change in IOP
Standard Deviation 11.41
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 13:00
|
-5.3 Percentage of change in IOP
Standard Deviation 10.75
|
-27.3 Percentage of change in IOP
Standard Deviation 11.41
|
-23.3 Percentage of change in IOP
Standard Deviation 11.09
|
-22.8 Percentage of change in IOP
Standard Deviation 12.54
|
-28.0 Percentage of change in IOP
Standard Deviation 12.43
|
-27.0 Percentage of change in IOP
Standard Deviation 13.50
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 1 17:00
|
-11.5 Percentage of change in IOP
Standard Deviation 10.56
|
-25.7 Percentage of change in IOP
Standard Deviation 12.62
|
-23.4 Percentage of change in IOP
Standard Deviation 10.96
|
-21.5 Percentage of change in IOP
Standard Deviation 14.33
|
-27.9 Percentage of change in IOP
Standard Deviation 13.10
|
-26.8 Percentage of change in IOP
Standard Deviation 11.24
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 9:00
|
-7.8 Percentage of change in IOP
Standard Deviation 10.30
|
-28.9 Percentage of change in IOP
Standard Deviation 13.13
|
-21.7 Percentage of change in IOP
Standard Deviation 13.84
|
-24.5 Percentage of change in IOP
Standard Deviation 10.62
|
-27.4 Percentage of change in IOP
Standard Deviation 11.69
|
-25.6 Percentage of change in IOP
Standard Deviation 13.56
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 17:00
|
-25.4 Percentage of change in IOP
Standard Deviation 11.12
|
-26.8 Percentage of change in IOP
Standard Deviation 14.63
|
-22.7 Percentage of change in IOP
Standard Deviation 10.37
|
-24.3 Percentage of change in IOP
Standard Deviation 12.06
|
-28.7 Percentage of change in IOP
Standard Deviation 12.82
|
-23.4 Percentage of change in IOP
Standard Deviation 11.96
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 2 13:00
|
-7.5 Percentage of change in IOP
Standard Deviation 12.08
|
-27.8 Percentage of change in IOP
Standard Deviation 10.89
|
-25.1 Percentage of change in IOP
Standard Deviation 12.42
|
-24.9 Percentage of change in IOP
Standard Deviation 10.09
|
-27.8 Percentage of change in IOP
Standard Deviation 11.83
|
-27.0 Percentage of change in IOP
Standard Deviation 11.93
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Week 6 17:00
|
-11.1 Percentage of change in IOP
Standard Deviation 13.12
|
-28.4 Percentage of change in IOP
Standard Deviation 12.62
|
-24.6 Percentage of change in IOP
Standard Deviation 9.63
|
-24.0 Percentage of change in IOP
Standard Deviation 12.84
|
-29.4 Percentage of change in IOP
Standard Deviation 11.86
|
-26.1 Percentage of change in IOP
Standard Deviation 12.12
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 9:00
|
-23.3 Percentage of change in IOP
Standard Deviation 13.33
|
-27.3 Percentage of change in IOP
Standard Deviation 13.11
|
-20.6 Percentage of change in IOP
Standard Deviation 9.64
|
-22.8 Percentage of change in IOP
Standard Deviation 11.48
|
-28.8 Percentage of change in IOP
Standard Deviation 11.66
|
-21.4 Percentage of change in IOP
Standard Deviation 12.63
|
|
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Month 3 at 13:00
|
-25.3 Percentage of change in IOP
Standard Deviation 13.15
|
-28.2 Percentage of change in IOP
Standard Deviation 12.30
|
-24.2 Percentage of change in IOP
Standard Deviation 10.00
|
-24.8 Percentage of change in IOP
Standard Deviation 11.33
|
-27.3 Percentage of change in IOP
Standard Deviation 11.73
|
-22.5 Percentage of change in IOP
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: WeeK 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=42 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 1- At Least 30% Reduction
|
0 Participants
|
16 Participants
|
9 Participants
|
8 Participants
|
14 Participants
|
18 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 1- At Least 20% Reduction
|
2 Participants
|
36 Participants
|
22 Participants
|
28 Participants
|
31 Participants
|
34 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 1- At Least 25% Reduction
|
0 Participants
|
23 Participants
|
18 Participants
|
15 Participants
|
25 Participants
|
27 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 2- At Least 20% Reduction
|
0 Participants
|
38 Participants
|
27 Participants
|
26 Participants
|
31 Participants
|
33 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 2- At Least 25% Reduction
|
0 Participants
|
27 Participants
|
21 Participants
|
22 Participants
|
27 Participants
|
24 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 2- At Least 30% Reduction
|
0 Participants
|
20 Participants
|
13 Participants
|
13 Participants
|
17 Participants
|
15 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 6- At Least 20% Reduction
|
3 Participants
|
37 Participants
|
30 Participants
|
28 Participants
|
30 Participants
|
28 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 6- At Least 25% Reduction
|
1 Participants
|
26 Participants
|
17 Participants
|
22 Participants
|
22 Participants
|
26 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Week 6- At Least 30% Reduction
|
1 Participants
|
19 Participants
|
12 Participants
|
18 Participants
|
15 Participants
|
14 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Month 3- At Least 20% Reduction
|
—
|
36 Participants
|
28 Participants
|
27 Participants
|
37 Participants
|
23 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Month 3- At Least 25% Reduction
|
—
|
23 Participants
|
15 Participants
|
22 Participants
|
28 Participants
|
18 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
Month 3- At Least 30% Reduction
|
—
|
16 Participants
|
7 Participants
|
11 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 6 and Month 3.Population: The number of participants is reduced due to missing data.
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Outcome measures
| Measure |
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
n=22 Participants
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
|
0.005% Latanoprost
n=44 Participants
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose 0.0005% DE-126
n=43 Participants
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose 0.001% DE-126
n=43 Participants
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose 0.002% DE-126
n=44 Participants
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose 0.003% DE-126
n=45 Participants
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
Week 2 -Reduced to 18 mmHg or Lower
|
1 Participants
|
30 Participants
|
18 Participants
|
22 Participants
|
27 Participants
|
23 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
Week 1 -Reduced to 18 mmHg or Lower
|
0 Participants
|
29 Participants
|
16 Participants
|
20 Participants
|
26 Participants
|
30 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
Week 6 -Reduced to 18 mmHg or Lower
|
2 Participants
|
27 Participants
|
24 Participants
|
22 Participants
|
25 Participants
|
23 Participants
|
|
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
Month 3 -Reduced to 18 mmHg or Lower
|
—
|
30 Participants
|
18 Participants
|
19 Participants
|
27 Participants
|
14 Participants
|
Adverse Events
Placebo P1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo P2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
0.005% Latanoprost
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Ultra-low Dose DE-126
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dose DE-126
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Medium Dose DE-126
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
High Dose of DE-126
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
High Dose of DE-126 Total
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
DE-126 Total
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo P1
n=22 participants at risk
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks.
|
Placebo P2
n=20 participants at risk
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3.
|
0.005% Latanoprost
n=44 participants at risk
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose DE-126
n=43 participants at risk
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose DE-126
n=43 participants at risk
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose DE-126
n=44 participants at risk
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose of DE-126
n=45 participants at risk
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose of DE-126 Total
n=65 participants at risk
Summarizes columns High dose of DE-126 and Placebo P2
|
DE-126 Total
n=195 participants at risk
Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
1/22 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/20 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/65 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/195 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
Other adverse events
| Measure |
Placebo P1
n=22 participants at risk
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks.
|
Placebo P2
n=20 participants at risk
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3.
|
0.005% Latanoprost
n=44 participants at risk
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
|
Ultra-low Dose DE-126
n=43 participants at risk
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Low Dose DE-126
n=43 participants at risk
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
Medium Dose DE-126
n=44 participants at risk
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose of DE-126
n=45 participants at risk
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
|
High Dose of DE-126 Total
n=65 participants at risk
Summarizes columns High dose of DE-126 and Placebo P2
|
DE-126 Total
n=195 participants at risk
Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.2%
1/45 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
3.1%
2/65 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.0%
2/195 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
10.0%
2/20 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
27.3%
12/44 • Number of events 13 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
11.6%
5/43 • Number of events 8 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
11.6%
5/43 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
20.5%
9/44 • Number of events 10 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
15.6%
7/45 • Number of events 8 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
13.8%
9/65 • Number of events 10 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
14.4%
28/195 • Number of events 33 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Eye disorders
Eye Irritation
|
4.5%
1/22 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/20 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.5%
2/44 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
7.0%
3/43 • Number of events 4 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/65 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
3/195 • Number of events 4 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/20 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
11.4%
5/44 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.7%
2/43 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/43 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
11.1%
5/45 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
7.7%
5/65 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.1%
8/195 • Number of events 8 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Eye disorders
Growth Of Eyelashes
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.5%
2/44 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
7.0%
3/43 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.7%
2/43 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
3.1%
6/195 • Number of events 6 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
6.8%
3/44 • Number of events 4 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/43 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/43 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
3/195 • Number of events 4 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
General disorders
Instillation Site Pain
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/20 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/43 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
6.8%
3/44 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.2%
1/45 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.6%
5/195 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
General disorders
Pyrexia
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Infections and infestations
Alveolar Osteitis
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
15.0%
3/20 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/44 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.6%
3/65 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
3/195 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.5%
2/44 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/43 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.7%
2/43 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.2%
1/45 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
3.1%
2/65 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.6%
5/195 • Number of events 5 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
4.5%
1/22 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/20 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/44 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
7.0%
3/43 • Number of events 3 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.7%
2/43 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
2.3%
1/44 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.4%
2/45 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
3.1%
2/65 • Number of events 2 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
4.1%
8/195 • Number of events 8 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/22 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
5.0%
1/20 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/43 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/44 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.00%
0/45 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
1.5%
1/65 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
0.51%
1/195 • Number of events 1 • Reporting time frame is from Inform Consent to end of the study at Month3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If Institution/Principal Investigator wishes to publish findings, they must submit draft to Santen at least 30 days prior, deleting Confidential Information if requested. Santen must be allowed up to ninety (90) days to determine if patent application is to be filed. Santen has right to first publication of Multi-Center Research results, but if publication doesn't occur within 12 months after completion, Institution/Principal Investigator may individually publish site's results.
- Publication restrictions are in place
Restriction type: OTHER