Trial Outcomes & Findings for Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT01110499)
NCT ID: NCT01110499
Last Updated: 2014-08-05
Results Overview
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Baseline, Day 7
Results posted on
2014-08-05
Participant Flow
This was a 2-part study. Patients were enrolled in and completed Part 1 of the study. Then, based on a review of the data from Part 1, a different formulation was selected for Part 2 (Formulation 7). New patients were then enrolled in Part 2 of the study. No patients from Part 1 were enrolled in Part 2 of the study.
Participant milestones
| Measure |
Part 1, AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 2, AGN-210961 Formulation 7
AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
|
Part 2, Bimatoprost Ophthalmic Solution 0.03%
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
14
|
14
|
39
|
40
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
14
|
14
|
14
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Part 1, AGN-210961 Formulation 1
n=14 Participants
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
n=14 Participants
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
n=14 Participants
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
n=14 Participants
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
n=14 Participants
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
n=14 Participants
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 2, AGN-210961 Formulation 7
n=39 Participants
AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
|
Part 2, Bimatoprost Ophthalmic Solution 0.03%
n=40 Participants
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Age, Customized
45 to 65 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
82 Participants
n=6 Participants
|
|
Age, Customized
>65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
77 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
105 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
58 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7Population: Safety Population: all treated patients
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Outcome measures
| Measure |
Part 1, AGN-210961 Formulation 1
n=14 Eyes
AGN-210961 Formulation 1 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
n=14 Eyes
AGN-210961 Formulation 2 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
n=14 Eyes
AGN-210961 Formulation 3 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
n=14 Eyes
AGN-210961 Formulation 4 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
n=14 Eyes
AGN-210961 Formulation 5 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
n=14 Eyes
AGN-210961 Formulation 6 in one eye once daily for 7 days.
|
Part 1, Bimatoprost Ophthalmic Solution 0.03%
n=84 Eyes
bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 8
|
21.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.84
|
21.3 Millimeters of Mercury (mmHg)
Standard Deviation 2.58
|
23.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.87
|
22.1 Millimeters of Mercury (mmHg)
Standard Deviation 4.04
|
22.2 Millimeters of Mercury (mmHg)
Standard Deviation 2.83
|
22.9 Millimeters of Mercury (mmHg)
Standard Deviation 2.95
|
22.3 Millimeters of Mercury (mmHg)
Standard Deviation 3.18
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 0
|
25.4 Millimeters of Mercury (mmHg)
Standard Deviation 2.5
|
25.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.71
|
24.3 Millimeters of Mercury (mmHg)
Standard Deviation 1.94
|
26.7 Millimeters of Mercury (mmHg)
Standard Deviation 3.60
|
24.4 Millimeters of Mercury (mmHg)
Standard Deviation 1.54
|
25.3 Millimeters of Mercury (mmHg)
Standard Deviation 2.23
|
25.3 Millimeters of Mercury (mmHg)
Standard Deviation 2.82
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 2
|
23.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.18
|
23.5 Millimeters of Mercury (mmHg)
Standard Deviation 2.53
|
23.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.64
|
23.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.27
|
23.1 Millimeters of Mercury (mmHg)
Standard Deviation 3.49
|
24.1 Millimeters of Mercury (mmHg)
Standard Deviation 3.25
|
23.4 Millimeters of Mercury (mmHg)
Standard Deviation 2.83
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 4
|
23.5 Millimeters of Mercury (mmHg)
Standard Deviation 2.53
|
23.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.55
|
23.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.64
|
23.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.72
|
23.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.46
|
23.7 Millimeters of Mercury (mmHg)
Standard Deviation 2.49
|
23.2 Millimeters of Mercury (mmHg)
Standard Deviation 2.76
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 6
|
22.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.53
|
22.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.46
|
24.4 Millimeters of Mercury (mmHg)
Standard Deviation 4.43
|
21.9 Millimeters of Mercury (mmHg)
Standard Deviation 3.88
|
22.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.60
|
22.4 Millimeters of Mercury (mmHg)
Standard Deviation 2.72
|
22.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.33
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline - Hour 12
|
22.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.98
|
21.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.03
|
21.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.86
|
21.6 Millimeters of Mercury (mmHg)
Standard Deviation 4.24
|
21.3 Millimeters of Mercury (mmHg)
Standard Deviation 1.98
|
20.8 Millimeters of Mercury (mmHg)
Standard Deviation 2.44
|
21.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.10
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7- Hour 0
|
-6.1 Millimeters of Mercury (mmHg)
Standard Deviation 4.22
|
-6.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.24
|
-5.9 Millimeters of Mercury (mmHg)
Standard Deviation 4.36
|
-6.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.87
|
-5.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.79
|
-5.6 Millimeters of Mercury (mmHg)
Standard Deviation 3.16
|
-6.3 Millimeters of Mercury (mmHg)
Standard Deviation 3.66
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7- Hour 2
|
-5.3 Millimeters of Mercury (mmHg)
Standard Deviation 3.00
|
-6.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.88
|
-6.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.72
|
-5.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.80
|
-5.3 Millimeters of Mercury (mmHg)
Standard Deviation 3.97
|
-5.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.71
|
-5.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.06
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7- Hour 4
|
-6.6 Millimeters of Mercury (mmHg)
Standard Deviation 4.27
|
-4.5 Millimeters of Mercury (mmHg)
Standard Deviation 2.45
|
-6.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.35
|
-4.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.48
|
-5.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.60
|
-5.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.68
|
-5.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.79
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7 - Hour 6
|
-5.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.23
|
-4.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.03
|
-6.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.05
|
-3.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.49
|
-5.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.23
|
-4.7 Millimeters of Mercury (mmHg)
Standard Deviation 2.63
|
-5.5 Millimeters of Mercury (mmHg)
Standard Deviation 2.92
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7- Hour 8
|
-5.9 Millimeters of Mercury (mmHg)
Standard Deviation 2.91
|
-4.8 Millimeters of Mercury (mmHg)
Standard Deviation 2.45
|
-5.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.31
|
-4.4 Millimeters of Mercury (mmHg)
Standard Deviation 2.49
|
-5.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.28
|
-4.9 Millimeters of Mercury (mmHg)
Standard Deviation 3.94
|
-6.2 Millimeters of Mercury (mmHg)
Standard Deviation 2.99
|
|
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Day 7- Hour 12
|
-5.4 Millimeters of Mercury (mmHg)
Standard Deviation 3.77
|
-4.9 Millimeters of Mercury (mmHg)
Standard Deviation 3.39
|
-4.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.69
|
-4.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.41
|
-3.7 Millimeters of Mercury (mmHg)
Standard Deviation 3.88
|
-3.7 Millimeters of Mercury (mmHg)
Standard Deviation 3.21
|
-5.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: Baseline, Day 29Population: Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
Outcome measures
| Measure |
Part 1, AGN-210961 Formulation 1
n=39 Participants
AGN-210961 Formulation 1 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
n=40 Participants
AGN-210961 Formulation 2 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
|
Part 1, Bimatoprost Ophthalmic Solution 0.03%
bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 0
|
24.63 Millimeters of Mercury (mmHg)
Standard Deviation 2.526
|
24.62 Millimeters of Mercury (mmHg)
Standard Deviation 2.465
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 2
|
23.40 Millimeters of Mercury (mmHg)
Standard Deviation 2.072
|
23.70 Millimeters of Mercury (mmHg)
Standard Deviation 3.182
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 4
|
22.25 Millimeters of Mercury (mmHg)
Standard Deviation 2.449
|
22.51 Millimeters of Mercury (mmHg)
Standard Deviation 3.507
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 6
|
21.97 Millimeters of Mercury (mmHg)
Standard Deviation 2.264
|
22.38 Millimeters of Mercury (mmHg)
Standard Deviation 3.492
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 8
|
21.28 Millimeters of Mercury (mmHg)
Standard Deviation 2.896
|
21.48 Millimeters of Mercury (mmHg)
Standard Deviation 3.354
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline - Hour 12
|
20.72 Millimeters of Mercury (mmHg)
Standard Deviation 3.162
|
20.94 Millimeters of Mercury (mmHg)
Standard Deviation 3.549
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 0
|
-7.44 Millimeters of Mercury (mmHg)
Standard Deviation 3.173
|
-8.63 Millimeters of Mercury (mmHg)
Standard Deviation 3.399
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 2
|
-7.40 Millimeters of Mercury (mmHg)
Standard Deviation 3.269
|
-8.51 Millimeters of Mercury (mmHg)
Standard Deviation 3.752
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 4
|
-6.25 Millimeters of Mercury (mmHg)
Standard Deviation 3.521
|
-7.39 Millimeters of Mercury (mmHg)
Standard Deviation 3.993
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 6
|
-6.31 Millimeters of Mercury (mmHg)
Standard Deviation 3.625
|
-6.92 Millimeters of Mercury (mmHg)
Standard Deviation 3.808
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 8
|
-6.15 Millimeters of Mercury (mmHg)
Standard Deviation 3.856
|
-6.31 Millimeters of Mercury (mmHg)
Standard Deviation 4.056
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Change from Baseline at Day 29 - Hour 12
|
-5.74 Millimeters of Mercury (mmHg)
Standard Deviation 4.086
|
-5.10 Millimeters of Mercury (mmHg)
Standard Deviation 4.054
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1, AGN-210961 Formulation 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1, AGN-210961 Formulation 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1, AGN-210961 Formulation 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1, AGN-210961 Formulation 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1, AGN-210961 Formulation 5
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1, AGN-210961 Formulation 6
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Part 2, AGN-210961 Formulation 7
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Part 2, Bimatoprost Ophthalmic Solution 0.03%
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1, AGN-210961 Formulation 1
n=14 participants at risk
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
n=14 participants at risk
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
n=14 participants at risk
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
n=14 participants at risk
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
n=14 participants at risk
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
n=14 participants at risk
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye
n=84 participants at risk
bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
|
Part 2, AGN-210961 Formulation 7
n=39 participants at risk
AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
|
Part 2, Bimatoprost Ophthalmic Solution 0.03%
n=40 participants at risk
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.6%
1/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or Oral Cavity Cancer
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.5%
1/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
Other adverse events
| Measure |
Part 1, AGN-210961 Formulation 1
n=14 participants at risk
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 2
n=14 participants at risk
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 3
n=14 participants at risk
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 4
n=14 participants at risk
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 5
n=14 participants at risk
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, AGN-210961 Formulation 6
n=14 participants at risk
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
|
Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye
n=84 participants at risk
bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
|
Part 2, AGN-210961 Formulation 7
n=39 participants at risk
AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
|
Part 2, Bimatoprost Ophthalmic Solution 0.03%
n=40 participants at risk
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.6%
1/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.4%
2/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.7%
3/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.5%
1/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Conjunctival Hyperaemia
|
35.7%
5/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
35.7%
5/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
42.9%
6/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
50.0%
42/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
41.0%
16/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
40.0%
16/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Punctate Keratitis
|
28.6%
4/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
35.7%
5/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
19.0%
16/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
17.9%
7/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
12.5%
5/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Corneal thickening
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
56.4%
22/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.5%
1/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Photophobia
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
4.8%
4/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
28.2%
11/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
14.3%
2/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.4%
2/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
17.9%
7/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.5%
1/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Eye Pain
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
4.8%
4/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
12.8%
5/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.5%
3/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
21.4%
3/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
6.0%
5/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
5.1%
2/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
12.5%
5/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
1.2%
1/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.6%
1/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.5%
3/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
5.1%
2/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
10.0%
4/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Nervous system disorders
Hemicephalalgia
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
7.1%
1/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
5.1%
2/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
2.5%
1/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/14
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/84
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
5.1%
2/39
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
0.00%
0/40
AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER