NCT03216902

A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Completed Phase 2 Results posted Last updated 23 October 2020

What this trial tests

Phase 2 trial testing Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution in Open-angle Glaucoma, Ocular Hypertension in 241 participants. Completed in 27 February 2018.

Timeline

25 July 2017

Primary endpoint
27 February 2018

27 February 2018

Quick facts

Lead sponsor	Santen Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	241
Start date	25 July 2017
Primary completion	27 February 2018
Estimated completion	27 February 2018
Sites	17 locations across Japan, United States

Drugs / interventions tested

• Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution — full drug profile →
• Topical ultra-low dose of DE-126 Ophthalmic Solution — full drug profile →
• Topical low dose of DE-126 Ophthalmic Solution
• Topical medium dose of DE-126 Ophthalmic Solution — full drug profile →
• Topical high dose of DE-126 Ophthalmic Solution — full drug profile →
• 0.005% Latanoprost Ophthalmic Solution — full drug profile →

Conditions studied

• Open-angle Glaucoma, Ocular Hypertension — all drugs for Open-angle Glaucoma, Ocular Hypertension →

Sponsor

Santen Inc. — full company profile →

Who can join

18 and older, any sex, with Open-angle Glaucoma, Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraocular Pressure in the Study Eye at Month 3 Primary · 9:00, 13:00 and 17:00 at Month 3

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.

9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	18.8	± 4.11
0.005% Latanoprost	18.1	± 3.73
Ultra-low Dose 0.0005% DE-126	19.7	± 3.27
Low Dose 0.001% DE-126	19.2	± 3.37
Medium Dose 0.002% DE-126	17.6	± 3.13
High Dose 0.003% DE-126	19.3	± 2.92

13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	17.6	± 3.18
0.005% Latanoprost	17.3	± 3.01
Ultra-low Dose 0.0005% DE-126	18.5	± 2.98
Low Dose 0.001% DE-126	18.1	± 2.99
Medium Dose 0.002% DE-126	17.4	± 2.39
High Dose 0.003% DE-126	18.7	± 3.17

17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	17.8	± 2.87
0.005% Latanoprost	17.2	± 3.10
Ultra-low Dose 0.0005% DE-126	18.3	± 2.55
Low Dose 0.001% DE-126	17.8	± 2.93
Medium Dose 0.002% DE-126	16.7	± 2.74
High Dose 0.003% DE-126	17.9	± 2.82

Intraocular Pressure in the Study Eye at Week 6 Secondary · 9:00, 13:00 and 17:00 at Week 6

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.

9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	23.2	± 0.66
Ultra-low Dose 0.0005% DE-126	19.0	± 0.46
Low Dose 0.001% DE-126	18.5	± 0.46
Medium Dose 0.002% DE-126	18.7	± 0.45
High Dose 0.003% DE-126	18.7	± 0.45

13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.2	± 0.61
Ultra-low Dose 0.0005% DE-126	18.2	± 0.42
Low Dose 0.001% DE-126	17.9	± 0.42
Medium Dose 0.002% DE-126	17.3	± 0.42
High Dose 0.003% DE-126	17.5	± 0.41

17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	21.6	± 0.62
Ultra-low Dose 0.0005% DE-126	17.8	± 0.43
Low Dose 0.001% DE-126	17.9	± 0.43
Medium Dose 0.002% DE-126	16.6	± 0.42
High Dose 0.003% DE-126	17.4	± 0.42

Intraocular Pressure in the Study Eye at Week 1 and Week 2 Secondary · 9:00, 13:00 and 17:00 at Week 1 and Week 2

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.

Week1 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.8	± 3.99
0.005% Latanoprost	17.7	± 2.67
Ultra-low Dose 0.0005% DE-126	19.4	± 3.32
Low Dose 0.001% DE-126	18.9	± 2.82
Medium Dose 0.002% DE-126	18.1	± 2.99
High Dose 0.003% DE-126	18.0	± 2.66

Week1 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.8	± 3.66
0.005% Latanoprost	17.5	± 2.25
Ultra-low Dose 0.0005% DE-126	18.7	± 3.28
Low Dose 0.001% DE-126	18.6	± 3.29
Medium Dose 0.002% DE-126	17.1	± 2.65
High Dose 0.003% DE-126	17.6	± 3.08

Week1 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	21.6	± 3.94
0.005% Latanoprost	17.4	± 2.43
Ultra-low Dose 0.0005% DE-126	18.1	± 2.94
Low Dose 0.001% DE-126	18.5	± 3.23
Medium Dose 0.002% DE-126	16.9	± 2.96
High Dose 0.003% DE-126	17.2	± 2.53

Week 2 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.7	± 3.70
0.005% Latanoprost	17.6	± 3.33
Ultra-low Dose 0.0005% DE-126	19.4	± 3.62
Low Dose 0.001% DE-126	18.7	± 2.73
Medium Dose 0.002% DE-126	17.9	± 3.11
High Dose 0.003% DE-126	18.3	± 3.13

Week 2 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.0	± 3.13
0.005% Latanoprost	17.4	± 2.45
Ultra-low Dose 0.0005% DE-126	18.2	± 2.93
Low Dose 0.001% DE-126	18.1	± 2.77
Medium Dose 0.002% DE-126	17.2	± 2.57
High Dose 0.003% DE-126	17.6	± 2.80

Week2 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	21.9	± 3.93
0.005% Latanoprost	16.9	± 2.49
Ultra-low Dose 0.0005% DE-126	18.2	± 2.94
Low Dose 0.001% DE-126	17.8	± 2.33
Medium Dose 0.002% DE-126	16.7	± 2.89
High Dose 0.003% DE-126	17.3	± 2.59

Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Secondary · Week 1, Week 2, Week 6 and Month 3.

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.

Week 1

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.4	± 3.48
0.005% Latanoprost	17.5	± 2.12
Ultra-low Dose 0.0005% DE-126	18.8	± 2.95
Low Dose 0.001% DE-126	18.7	± 2.88
Medium Dose 0.002% DE-126	17.4	± 2.64
High Dose 0.003% DE-126	17.6	± 2.59

Week 2

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	22.2	± 3.33
0.005% Latanoprost	17.3	± 2.51
Ultra-low Dose 0.0005% DE-126	18.6	± 2.92
Low Dose 0.001% DE-126	18.2	± 2.37
Medium Dose 0.002% DE-126	17.3	± 2.58
High Dose 0.003% DE-126	17.7	± 2.52

Week 6

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	21.7	± 2.90
0.005% Latanoprost	17.3	± 2.80
Ultra-low Dose 0.0005% DE-126	18.4	± 2.40
Low Dose 0.001% DE-126	18.1	± 2.50
Medium Dose 0.002% DE-126	17.5	± 2.69
High Dose 0.003% DE-126	17.8	± 2.69

Month 3

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	18.1	± 3.14
0.005% Latanoprost	17.5	± 2.98
Ultra-low Dose 0.0005% DE-126	18.8	± 2.66
Low Dose 0.001% DE-126	18.4	± 2.94
Medium Dose 0.002% DE-126	17.2	± 2.47
High Dose 0.003% DE-126	18.6	± 2.71

Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Secondary · Week 1, Week 2, Week 6 and Month 3.

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.

Week 1

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.1	± 2.13
0.005% Latanoprost	-6.7	± 2.98
Ultra-low Dose 0.0005% DE-126	-5.5	± 2.41
0.001% Low Dose DE-126	-5.6	± 2.84
Medium Dose 0.002% DE-126	-6.7	± 3.19
High Dose 0.003% DE-126	-6.6	± 2.92

Week 2

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.0	± 2.15
0.005% Latanoprost	-7.0	± 3.13
Ultra-low Dose 0.0005% DE-126	-5.8	± 3.02
0.001% Low Dose DE-126	-6.0	± 2.35
Medium Dose 0.002% DE-126	-6.9	± 2.87
High Dose 0.003% DE-126	-6.5	± 2.94

Week 6

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.3	± 2.49
0.005% Latanoprost	-7.0	± 3.09
Ultra-low Dose 0.0005% DE-126	-5.9	± 2.73
0.001% Low Dose DE-126	-6.1	± 2.59
Medium Dose 0.002% DE-126	-6.6	± 3.08
High Dose 0.003% DE-126	-6.4	± 2.68

Month 3

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-5.9	± 2.65
0.005% Latanoprost	-6.7	± 3.24
Ultra-low Dose 0.0005% DE-126	-5.5	± 2.11
0.001% Low Dose DE-126	-5.9	± 2.71
Medium Dose 0.002% DE-126	-6.9	± 2.96
High Dose 0.003% DE-126	-5.5	± 2.67

Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Secondary · Week 1, Week 2, Week 6 and Month 3.

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.

Week 1

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-8.6	± 8.15
0.005% Latanoprost	-27.3	± 10.60
Ultra-low Dose 0.0005% DE-126	-22.8	± 9.59
Low Dose 0.001% DE-126	-22.9	± 10.78
Medium Dose 0.002% DE-126	-27.4	± 11.48
High Dose 0.003% DE-126	-27.0	± 11.12

Week 2

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-8.6	± 8.74
0.005% Latanoprost	-28.3	± 11.05
Ultra-low Dose 0.0005% DE-126	-23.5	± 11.28
Low Dose 0.001% DE-126	-24.7	± 8.90
Medium Dose 0.002% DE-126	-28.2	± 10.48
High Dose 0.003% DE-126	-26.4	± 11.27

Week 6

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-9.4	± 10.31
0.005% Latanoprost	-28.5	± 11.23
Ultra-low Dose 0.0005% DE-126	-24.0	± 9.58
Low Dose 0.001% DE-126	-25.1	± 9.83
Medium Dose 0.002% DE-126	-27.2	± 10.72
High Dose 0.003% DE-126	-26.2	± 10.51

Month 3

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-24.7	± 11.26
0.005% Latanoprost	-27.5	± 12.11
Ultra-low Dose 0.0005% DE-126	-22.6	± 8.22
Low Dose 0.001% DE-126	-24.1	± 10.45
Medium Dose 0.002% DE-126	-28.4	± 10.54
High Dose 0.003% DE-126	-22.7	± 10.79

Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit Secondary · 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.

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.

Week 1 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.1	± 2.68
0.005% Latanoprost	-7.3	± 3.65
Ultra-low Dose 0.0005% DE-126	-5.3	± 2.65
Low Dose 0.001% DE-126	-6.0	± 3.10
Medium Dose 0.002% DE-126	-6.7	± 3.70
High Dose 0.003% DE-126	-6.6	± 3.24

Week 1 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-1.2	± 2.73
0.005% Latanoprost	-6.8	± 3.35
Ultra-low Dose 0.0005% DE-126	-5.7	± 2.73
Low Dose 0.001% DE-126	-5.6	± 3.26
Medium Dose 0.002% DE-126	-6.8	± 3.59
High Dose 0.003% DE-126	-6.7	± 3.63

Week 1 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.8	± 2.81
0.005% Latanoprost	-6.2	± 3.33
Ultra-low Dose 0.0005% DE-126	-5.6	± 2.83
Low Dose 0.001% DE-126	-5.2	± 3.62
Medium Dose 0.002% DE-126	-6.7	± 3.60
High Dose 0.003% DE-126	-6.4	± 2.98

Week 2 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-1.9	± 2.66
0.005% Latanoprost	-7.4	± 4.03
Ultra-low Dose 0.0005% DE-126	-5.5	± 3.52
Low Dose 0.001% DE-126	-6.2	± 3.00
Medium Dose 0.002% DE-126	-6.9	± 3.32
High Dose 0.003% DE-126	-6.4	± 3.66

Week 2 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-1.8	± 2.89
0.005% Latanoprost	-6.8	± 3.02
Ultra-low Dose 0.0005% DE-126	-6.2	± 3.36
Low Dose 0.001% DE-126	-6.0	± 2.62
Medium Dose 0.002% DE-126	-6.8	± 3.27
High Dose 0.003% DE-126	-6.7	± 3.22

Week 2 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.4	± 2.57
0.005% Latanoprost	-6.7	± 3.39
Ultra-low Dose 0.0005% DE-126	-5.7	± 3.36
Low Dose 0.001% DE-126	-5.8	± 2.52
Medium Dose 0.002% DE-126	-6.9	± 3.29
High Dose 0.003% DE-126	-6.3	± 3.15

Week 6 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.0	± 2.59
0.005% Latanoprost	-7.0	± 3.84
Ultra-low Dose 0.0005% DE-126	-5.7	± 3.03
Low Dose 0.001% DE-126	-6.4	± 2.83
Medium Dose 0.002% DE-126	-6.1	± 3.21
High Dose 0.003% DE-126	-6.1	± 3.55

Week 6 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-2.1	± 2.66
0.005% Latanoprost	-7.0	± 3.30
Ultra-low Dose 0.0005% DE-126	-6.1	± 3.65
Low Dose 0.001% DE-126	-6.2	± 2.64
Medium Dose 0.002% DE-126	-6.8	± 3.67
High Dose 0.003% DE-126	-6.8	± 3.11

Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit Secondary · 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.

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.

Week 1 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-8.7	± 9.58
0.005% Latanoprost	-28.5	± 12.00
Ultra-low Dose 0.0005% DE-126	-21.6	± 10.44
Low Dose 0.001% DE-126	-23.7	± 11.01
Medium Dose 0.002% DE-126	-26.5	± 12.64
High Dose 0.003% DE-126	-26.5	± 11.41

Week 1 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-5.3	± 10.75
0.005% Latanoprost	-27.3	± 11.41
Ultra-low Dose 0.0005% DE-126	-23.3	± 11.09
Low Dose 0.001% DE-126	-22.8	± 12.54
Medium Dose 0.002% DE-126	-28.0	± 12.43
High Dose 0.003% DE-126	-27.0	± 13.50

Week 1 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-11.5	± 10.56
0.005% Latanoprost	-25.7	± 12.62
Ultra-low Dose 0.0005% DE-126	-23.4	± 10.96
Low Dose 0.001% DE-126	-21.5	± 14.33
Medium Dose 0.002% DE-126	-27.9	± 13.10
High Dose 0.003% DE-126	-26.8	± 11.24

Week 2 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-7.8	± 10.30
0.005% Latanoprost	-28.9	± 13.13
Ultra-low Dose 0.0005% DE-126	-21.7	± 13.84
Low Dose 0.001% DE-126	-24.5	± 10.62
Medium Dose 0.002% DE-126	-27.4	± 11.69
High Dose 0.003% DE-126	-25.6	± 13.56

Week 2 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-7.5	± 12.08
0.005% Latanoprost	-27.8	± 10.89
Ultra-low Dose 0.0005% DE-126	-25.1	± 12.42
Low Dose 0.001% DE-126	-24.9	± 10.09
Medium Dose 0.002% DE-126	-27.8	± 11.83
High Dose 0.003% DE-126	-27.0	± 11.93

Week 2 17:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-9.9	± 10.16
0.005% Latanoprost	-27.8	± 12.69
Ultra-low Dose 0.0005% DE-126	-23.5	± 12.42
Low Dose 0.001% DE-126	-24.4	± 9.53
Medium Dose 0.002% DE-126	-28.8	± 12.48
High Dose 0.003% DE-126	-26.3	± 11.95

Week 6 9:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-8.4	± 10.71
0.005% Latanoprost	-27.5	± 12.44
Ultra-low Dose 0.0005% DE-126	-22.8	± 10.71
Low Dose 0.001% DE-126	-25.3	± 9.93
Medium Dose 0.002% DE-126	-24.4	± 11.45
High Dose 0.003% DE-126	-24.3	± 13.78

Week 6 13:00

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	-8.6	± 10.89
0.005% Latanoprost	-28.8	± 12.25
Ultra-low Dose 0.0005% DE-126	-24.5	± 12.69
Low Dose 0.001% DE-126	-25.6	± 9.85
Medium Dose 0.002% DE-126	-27.7	± 12.16
High Dose 0.003% DE-126	-27.8	± 11.27

Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit Secondary · WeeK 1, Week 2, Week 6 and Month 3.

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%.

Week 1- At Least 20% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	2
0.005% Latanoprost	36
Ultra-low Dose 0.0005% DE-126	22
Low Dose 0.001% DE-126	28
Medium Dose 0.002% DE-126	31
High Dose 0.003% DE-126	34

Week 1- At Least 25% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	23
Ultra-low Dose 0.0005% DE-126	18
Low Dose 0.001% DE-126	15
Medium Dose 0.002% DE-126	25
High Dose 0.003% DE-126	27

Week 1- At Least 30% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	16
Ultra-low Dose 0.0005% DE-126	9
Low Dose 0.001% DE-126	8
Medium Dose 0.002% DE-126	14
High Dose 0.003% DE-126	18

Week 2- At Least 20% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	38
Ultra-low Dose 0.0005% DE-126	27
Low Dose 0.001% DE-126	26
Medium Dose 0.002% DE-126	31
High Dose 0.003% DE-126	33

Week 2- At Least 25% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	27
Ultra-low Dose 0.0005% DE-126	21
Low Dose 0.001% DE-126	22
Medium Dose 0.002% DE-126	27
High Dose 0.003% DE-126	24

Week 2- At Least 30% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	20
Ultra-low Dose 0.0005% DE-126	13
Low Dose 0.001% DE-126	13
Medium Dose 0.002% DE-126	17
High Dose 0.003% DE-126	15

Week 6- At Least 20% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	3
0.005% Latanoprost	37
Ultra-low Dose 0.0005% DE-126	30
Low Dose 0.001% DE-126	28
Medium Dose 0.002% DE-126	30
High Dose 0.003% DE-126	28

Week 6- At Least 25% Reduction

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	1
0.005% Latanoprost	26
Ultra-low Dose 0.0005% DE-126	17
Low Dose 0.001% DE-126	22
Medium Dose 0.002% DE-126	22
High Dose 0.003% DE-126	26

Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit Secondary · Week 1, Week 2, Week 6 and Month 3.

A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.

Week 1 -Reduced to 18 mmHg or Lower

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	0
0.005% Latanoprost	29
Ultra-low Dose 0.0005% DE-126	16
Low Dose 0.001% DE-126	20
Medium Dose 0.002% DE-126	26
High Dose 0.003% DE-126	30

Week 2 -Reduced to 18 mmHg or Lower

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	1
0.005% Latanoprost	30
Ultra-low Dose 0.0005% DE-126	18
Low Dose 0.001% DE-126	22
Medium Dose 0.002% DE-126	27
High Dose 0.003% DE-126	23

Week 6 -Reduced to 18 mmHg or Lower

Group	Value	95% CI
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126	2
0.005% Latanoprost	27
Ultra-low Dose 0.0005% DE-126	24
Low Dose 0.001% DE-126	22
Medium Dose 0.002% DE-126	25
High Dose 0.003% DE-126	23

Month 3 -Reduced to 18 mmHg or Lower

Group	Value	95% CI
0.005% Latanoprost	30
Ultra-low Dose 0.0005% DE-126	18
Low Dose 0.001% DE-126	19
Medium Dose 0.002% DE-126	27
High Dose 0.003% DE-126	14

Adverse events — posted to ClinicalTrials.gov

Time frame: Reporting time frame is from Inform Consent to end of the study at Month3.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo P1

Serious: 1/22 (5%)

Deaths: 0/22

Placebo P2

Serious: 0/20 (0%)

Deaths: 0/20

0.005% Latanoprost

Serious: 0/44 (0%)

Deaths: 0/44

Ultra-low Dose DE-126

Serious: 0/43 (0%)

Deaths: 0/43

Low Dose DE-126

Serious: 0/43 (0%)

Deaths: 0/43

Medium Dose DE-126

Serious: 0/44 (0%)

Deaths: 0/44

High Dose of DE-126

Serious: 0/45 (0%)

Deaths: 0/45

High Dose of DE-126 Total

Serious: 0/65 (0%)

Deaths: 0/65

DE-126 Total

Serious: 0/195 (0%)

Deaths: 0/195

Serious adverse events (1 terms)

Reaction	System	Placebo P1	Placebo P2	0.005% Latanoprost	Ultra-low Dose DE-126	Low Dose DE-126	Medium Dose DE-126	High Dose of DE-126	High Dose of DE-126 Total	DE-126 Total
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	Placebo P1	Placebo P2	0.005% Latanoprost	Ultra-low Dose DE-126	Low Dose DE-126	Medium Dose DE-126	High Dose of DE-126	High Dose of DE-126 Total	DE-126 Total
Conjunctival Hyperaemia	Eye disorders	—	—	—	—	—	—	—	—	—
Eye Pruritus	Eye disorders	—	—	—	—	—	—	—	—	—
Viral Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Growth Of Eyelashes	Eye disorders	—	—	—	—	—	—	—	—	—
Instillation Site Pain	General disorders	—	—	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Eye Irritation	Eye disorders	—	—	—	—	—	—	—	—	—
Lacrimation Increased	Eye disorders	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Alveolar Osteitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Hepatic Enzyme Increased	Investigations	—	—	—	—	—	—	—	—	—
Hypertonic Bladder	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Skin Lesion	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Phlebitis	Vascular disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Muscular weakness.

Data from ClinicalTrials.gov NCT03216902 adverse events section.

Sponsor's own description

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.

The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development.
   Storgaard L, Tran TL, Freiberg JC, Hauser AS, et al · · 2021 · cited 50× · PMID 34589504 · DOI 10.3389/fmed.2021.733080
2. Discovery, characterization and clinical utility of prostaglandin agonists for the treatment of glaucoma.
   Klimko PG, Sharif NA. · · 2019 · cited 45× · PMID 29665040 · DOI 10.1111/bph.14327
3. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study.
   Wirta DL, Kuwayama Y, Lu F, Shao H, et al · · 2022 · cited 10× · PMID 35167779 · DOI 10.1089/jop.2021.0077