Ocular Hypertension, Primary Open-Angle Glaucoma
Conditions
Brief summary
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.
Interventions
DRUGAGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
DRUGAGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Ocular hypertension or primary open-angle glaucoma in each eye
Exclusion criteria
* Any active ocular disease * Anticipated wearing of contact lenses during study * Anticipated use of artificial tears during study * Contraindication to pupil dilatation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline, Day 7 | 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. |
| Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline, Day 29 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| 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. | 14 |
| 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. | 14 |
| 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. | 14 |
| 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. | 14 |
| 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. | 39 |
| Part 2, Bimatoprost Ophthalmic Solution 0.03% bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. | 40 |
| Total | 163 |
Baseline characteristics
| Characteristic | Total | Part 1, AGN-210961 Formulation 1 | Part 1, AGN-210961 Formulation 2 | Part 1, AGN-210961 Formulation 3 | Part 1, AGN-210961 Formulation 4 | Part 1, AGN-210961 Formulation 5 | Part 1, AGN-210961 Formulation 6 | Part 2, AGN-210961 Formulation 7 | Part 2, Bimatoprost Ophthalmic Solution 0.03% |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 45 to 65 years | 82 Participants | 11 Participants | 3 Participants | 6 Participants | 8 Participants | 6 Participants | 7 Participants | 18 Participants | 23 Participants |
| Age, Customized <45 years | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized >65 years | 77 Participants | 3 Participants | 10 Participants | 7 Participants | 5 Participants | 8 Participants | 7 Participants | 21 Participants | 16 Participants |
| Sex: Female, Male Female | 105 Participants | 12 Participants | 9 Participants | 10 Participants | 9 Participants | 7 Participants | 7 Participants | 24 Participants | 27 Participants |
| Sex: Female, Male Male | 58 Participants | 2 Participants | 5 Participants | 4 Participants | 5 Participants | 7 Participants | 7 Participants | 15 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 14 | 9 / 14 | 10 / 14 | 6 / 14 | 7 / 14 | 5 / 14 | 53 / 84 | 29 / 39 | 19 / 40 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 84 | 1 / 39 | 1 / 40 |
Outcome results
Primary
Part 1: Change From Baseline in Intraocular Pressure (IOP)
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.
Time frame: Baseline, Day 7
Population: Safety Population: all treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 22.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.98 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.18 |
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.5 |
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.5 Millimeters of Mercury (mmHg) | Standard Deviation 2.53 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.53 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 21.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.84 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.71 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -4.9 Millimeters of Mercury (mmHg) | Standard Deviation 3.39 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.55 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -4.5 Millimeters of Mercury (mmHg) | Standard Deviation 3.03 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 21.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.03 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -6.3 Millimeters of Mercury (mmHg) | Standard Deviation 4.24 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -4.5 Millimeters of Mercury (mmHg) | Standard Deviation 2.45 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 2 | -6.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.88 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.5 Millimeters of Mercury (mmHg) | Standard Deviation 2.53 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.46 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -4.8 Millimeters of Mercury (mmHg) | Standard Deviation 2.45 |
| Part 1, AGN-210961 Formulation 2 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 21.3 Millimeters of Mercury (mmHg) | Standard Deviation 2.58 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -4.8 Millimeters of Mercury (mmHg) | Standard Deviation 3.69 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 23.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.87 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.64 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -6.7 Millimeters of Mercury (mmHg) | Standard Deviation 4.05 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 24.4 Millimeters of Mercury (mmHg) | Standard Deviation 4.43 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -5.8 Millimeters of Mercury (mmHg) | Standard Deviation 3.31 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 21.8 Millimeters of Mercury (mmHg) | Standard Deviation 3.86 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 2 | -6.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.72 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -6.3 Millimeters of Mercury (mmHg) | Standard Deviation 4.35 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -5.9 Millimeters of Mercury (mmHg) | Standard Deviation 4.36 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.64 |
| Part 1, AGN-210961 Formulation 3 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 24.3 Millimeters of Mercury (mmHg) | Standard Deviation 1.94 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -4.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.49 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 26.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.6 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.27 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.72 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 21.9 Millimeters of Mercury (mmHg) | Standard Deviation 3.88 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 22.1 Millimeters of Mercury (mmHg) | Standard Deviation 4.04 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 21.6 Millimeters of Mercury (mmHg) | Standard Deviation 4.24 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -6.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.87 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 2 | -5.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.8 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -4.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.48 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -3.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.49 |
| Part 1, AGN-210961 Formulation 4 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -4.8 Millimeters of Mercury (mmHg) | Standard Deviation 3.41 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -5.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.6 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 24.4 Millimeters of Mercury (mmHg) | Standard Deviation 1.54 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.46 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.6 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -5.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.23 |
| Part 1, AGN-210961 Formulation 5 | 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 3.97 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -5.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.79 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -5.5 Millimeters of Mercury (mmHg) | Standard Deviation 3.28 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 22.2 Millimeters of Mercury (mmHg) | Standard Deviation 2.83 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.1 Millimeters of Mercury (mmHg) | Standard Deviation 3.49 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 21.3 Millimeters of Mercury (mmHg) | Standard Deviation 1.98 |
| Part 1, AGN-210961 Formulation 5 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -3.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.88 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -5.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.16 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 22.9 Millimeters of Mercury (mmHg) | Standard Deviation 2.95 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 2 | -5.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.71 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.72 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -5.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.68 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.7 Millimeters of Mercury (mmHg) | Standard Deviation 2.49 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -3.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.21 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -4.7 Millimeters of Mercury (mmHg) | Standard Deviation 2.63 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 24.1 Millimeters of Mercury (mmHg) | Standard Deviation 3.25 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -4.9 Millimeters of Mercury (mmHg) | Standard Deviation 3.94 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.3 Millimeters of Mercury (mmHg) | Standard Deviation 2.23 |
| Part 1, AGN-210961 Formulation 6 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 20.8 Millimeters of Mercury (mmHg) | Standard Deviation 2.44 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 0 | -6.3 Millimeters of Mercury (mmHg) | Standard Deviation 3.66 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.5 Millimeters of Mercury (mmHg) | Standard Deviation 3.33 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 2 | -5.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.06 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 12 | -5.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.73 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 8 | -6.2 Millimeters of Mercury (mmHg) | Standard Deviation 2.99 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.3 Millimeters of Mercury (mmHg) | Standard Deviation 2.82 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 8 | 22.3 Millimeters of Mercury (mmHg) | Standard Deviation 3.18 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 4 | 23.2 Millimeters of Mercury (mmHg) | Standard Deviation 2.76 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 12 | 21.5 Millimeters of Mercury (mmHg) | Standard Deviation 3.1 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7 - Hour 6 | -5.5 Millimeters of Mercury (mmHg) | Standard Deviation 2.92 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Day 7- Hour 4 | -5.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.79 |
| Part 1, Bimatoprost Ophthalmic Solution 0.03% | Part 1: Change From Baseline in Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.83 |
Primary
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
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.
Time frame: Baseline, Day 29
Population: Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 24.63 Millimeters of Mercury (mmHg) | Standard Deviation 2.526 |
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.40 Millimeters of Mercury (mmHg) | Standard Deviation 2.072 |
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 4 | 22.25 Millimeters of Mercury (mmHg) | Standard Deviation 2.449 |
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 6 | 21.97 Millimeters of Mercury (mmHg) | Standard Deviation 2.264 |
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 8 | 21.28 Millimeters of Mercury (mmHg) | Standard Deviation 2.896 |
| Part 1, AGN-210961 Formulation 1 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 12 | 20.72 Millimeters of Mercury (mmHg) | Standard Deviation 3.162 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 1 | 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 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 8 | -6.31 Millimeters of Mercury (mmHg) | Standard Deviation 4.056 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 24.62 Millimeters of Mercury (mmHg) | Standard Deviation 2.465 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 0 | -8.63 Millimeters of Mercury (mmHg) | Standard Deviation 3.399 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 2 | 23.70 Millimeters of Mercury (mmHg) | Standard Deviation 3.182 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 6 | -6.92 Millimeters of Mercury (mmHg) | Standard Deviation 3.808 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 4 | 22.51 Millimeters of Mercury (mmHg) | Standard Deviation 3.507 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 2 | -8.51 Millimeters of Mercury (mmHg) | Standard Deviation 3.752 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 6 | 22.38 Millimeters of Mercury (mmHg) | Standard Deviation 3.492 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 12 | -5.10 Millimeters of Mercury (mmHg) | Standard Deviation 4.054 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 8 | 21.48 Millimeters of Mercury (mmHg) | Standard Deviation 3.354 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 4 | -7.39 Millimeters of Mercury (mmHg) | Standard Deviation 3.993 |
| Part 1, AGN-210961 Formulation 2 | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 12 | 20.94 Millimeters of Mercury (mmHg) | Standard Deviation 3.549 |