Ocular Hypertension, Glaucoma
Conditions
Brief summary
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.
Interventions
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
DRUGAGN-210669 ophthalmic solution, 0.025%
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
DRUGAGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ocular hypertension or primary open-angle glaucoma * Females of non-childbearing potential * Subject requires IOP-lowering therapy in both eyes * IOP ≥ 22 mm Hg and ≤ 34 mm Hg * Has a visual acuity score of 20/100 or better in each eye
Exclusion criteria
* Uncontrolled systemic disease * Active ocular disease * Alteration of existing chronic systemic medications * Known allergy or sensitivity to the study medications * Ophthalmic corticosteroids * Visual field loss which in the opinion of the investigator is functionally significant * History of ocular laser, intraocular surgery, or refractive surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline, Day 14 Hour 0 | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | Baseline, Day 14 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-210669 Ophthalmic Solution, 0.075% AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. | 36 |
| AGN-210669 Ophthalmic Solution, 0.05% AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. | 34 |
| AGN-210669 Ophthalmic Solution, 0.025% AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. | 34 |
| Bimatoprost Ophthalmic Solution 0.03% Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. | 31 |
| AGN-210669 Vehicle Ophthalmic Solution AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. | 37 |
| Total | 172 |
Baseline characteristics
| Characteristic | AGN-210669 Ophthalmic Solution, 0.075% | AGN-210669 Ophthalmic Solution, 0.05% | AGN-210669 Ophthalmic Solution, 0.025% | Bimatoprost Ophthalmic Solution 0.03% | AGN-210669 Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|---|---|
| Age, Customized <45 years | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Age, Customized >65 years | 12 Participants | 14 Participants | 14 Participants | 12 Participants | 16 Participants | 68 Participants |
| Age, Customized Between 45 and 65 years | 23 Participants | 20 Participants | 18 Participants | 18 Participants | 18 Participants | 97 Participants |
| Sex: Female, Male Female | 22 Participants | 18 Participants | 21 Participants | 20 Participants | 20 Participants | 101 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 13 Participants | 11 Participants | 17 Participants | 71 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 36 | 18 / 34 | 9 / 34 | 20 / 31 | 5 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 | 0 / 34 | 0 / 31 | 0 / 37 |
Outcome results
Primary
Change From Baseline in Average Eye Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Day 14 Hour 0
Population: Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-210669 Ophthalmic Solution, 0.075% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.350 Millimeters of Mercury (mmHg) | Standard Deviation 2.8018 |
| AGN-210669 Ophthalmic Solution, 0.075% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 14 - Hour 0 | -5.807 Millimeters of Mercury (mmHg) | Standard Deviation 3.7007 |
| AGN-210669 Ophthalmic Solution, 0.05% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.318 Millimeters of Mercury (mmHg) | Standard Deviation 2.9377 |
| AGN-210669 Ophthalmic Solution, 0.05% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 14 - Hour 0 | -5.197 Millimeters of Mercury (mmHg) | Standard Deviation 3.1947 |
| AGN-210669 Ophthalmic Solution, 0.025% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.341 Millimeters of Mercury (mmHg) | Standard Deviation 2.6375 |
| AGN-210669 Ophthalmic Solution, 0.025% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 14 - Hour 0 | -4.068 Millimeters of Mercury (mmHg) | Standard Deviation 2.852 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 14 - Hour 0 | -6.575 Millimeters of Mercury (mmHg) | Standard Deviation 3.2184 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 24.650 Millimeters of Mercury (mmHg) | Standard Deviation 2.0622 |
| AGN-210669 Vehicle Ophthalmic Solution | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.507 Millimeters of Mercury (mmHg) | Standard Deviation 2.9004 |
| AGN-210669 Vehicle Ophthalmic Solution | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 14 - Hour 0 | -2.382 Millimeters of Mercury (mmHg) | Standard Deviation 2.9396 |
Secondary
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.
Time frame: Baseline, Day 14
Population: Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-210669 Ophthalmic Solution, 0.075% | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | 62.9 Percentage of Patients |
| AGN-210669 Ophthalmic Solution, 0.05% | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | 57.6 Percentage of Patients |
| AGN-210669 Ophthalmic Solution, 0.025% | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | 30.3 Percentage of Patients |
| Bimatoprost Ophthalmic Solution 0.03% | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | 63.3 Percentage of Patients |
| AGN-210669 Vehicle Ophthalmic Solution | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | 2.8 Percentage of Patients |