Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
Interventions
DRUGAGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.
One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days
DRUGAGN-207281 vehicle ophthalmic solution (Placebo)
One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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 * Requires IOP-lowering therapy in both eyes * Visual acuity score of 20/100 or better in each eye
Exclusion criteria
* Experienced significant weight change (over 10 pounds) within 60 days * History of alcohol or drug addiction * History of migraines or frequent headaches * Anticipated wearing of contact lenses during the study * Required chronic use of ocular medications during study * Eye surgery within 6 months * Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months * Use of oral, intramuscular, intravenous corticosteroids within 21 days * Use of ophthalmic corticosteroids within 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Day 14 | Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Concentration of AGN-207281 in Plasma at Day 7 | Day 7 | Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. |
| Mean Concentration of AGN-207281 in Plasma at Day 14 | Day 14 | Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. |
Countries
United States
Participant flow
Pre-assignment details
Patients in the AGN-207281 ophthalmic solution arm received AGN-207281 ophthalmic solution 0.1% on Days 1 to 7 and AGN-207281 ophthalmic solution 0.3% on Days 8 to 14.
Participants by arm
| Arm | Count |
|---|---|
| AGN-207281 Ophthalmic Solution AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 | 21 |
| Timolol Ophthalmic Solution 0.5% timolol ophthalmic solution 0.5% | 19 |
| Placebo AGN-207281 vehicle ophthalmic solution (Placebo) | 10 |
| Total | 50 |
Baseline characteristics
| Characteristic | AGN-207281 Ophthalmic Solution | Timolol Ophthalmic Solution 0.5% | Placebo | Total |
|---|---|---|---|---|
| Age, Customized <45 years | 0 participants | 0 participants | 1 participants | 1 participants |
| Age, Customized >65 years | 14 participants | 12 participants | 7 participants | 33 participants |
| Age, Customized Between 45 and 65 years | 7 participants | 7 participants | 2 participants | 16 participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 7 Participants | 28 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 3 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 21 | 19 / 19 | 2 / 10 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Day 14
Population: Safety population, which consisted of all patients who started the study and received treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 0 | 25.98 Millimeters of mercury (mm Hg) | Standard Deviation 2.581 |
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 2 | 25.93 Millimeters of mercury (mm Hg) | Standard Deviation 3.207 |
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 8 | 24.69 Millimeters of mercury (mm Hg) | Standard Deviation 2.61 |
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 0 | -4.17 Millimeters of mercury (mm Hg) | Standard Deviation 2.825 |
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 2 | -4.38 Millimeters of mercury (mm Hg) | Standard Deviation 3.244 |
| AGN-207281 Ophthalmic Solution | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 8 | -4.02 Millimeters of mercury (mm Hg) | Standard Deviation 2.826 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 8 | -4.00 Millimeters of mercury (mm Hg) | Standard Deviation 3 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 0 | 26.58 Millimeters of mercury (mm Hg) | Standard Deviation 2.673 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 0 | -6.16 Millimeters of mercury (mm Hg) | Standard Deviation 3.189 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 2 | -6.08 Millimeters of mercury (mm Hg) | Standard Deviation 2.955 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 2 | 26.61 Millimeters of mercury (mm Hg) | Standard Deviation 3.125 |
| Timolol Ophthalmic Solution 0.5% | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 8 | 24.82 Millimeters of mercury (mm Hg) | Standard Deviation 2.578 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 2 | 26.30 Millimeters of mercury (mm Hg) | Standard Deviation 2.781 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 8 | 25.25 Millimeters of mercury (mm Hg) | Standard Deviation 2.889 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 8 | -1.70 Millimeters of mercury (mm Hg) | Standard Deviation 1.814 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 0 | -1.10 Millimeters of mercury (mm Hg) | Standard Deviation 2.039 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Baseline, Hour 0 | 26.45 Millimeters of mercury (mm Hg) | Standard Deviation 2.661 |
| Placebo | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from Baseline at Day 14, Hour 2 | -1.75 Millimeters of mercury (mm Hg) | Standard Deviation 2.69 |
Secondary
Mean Concentration of AGN-207281 in Plasma at Day 14
Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Time frame: Day 14
Population: The analysis population included all patients that started the study and were treated with AGN-207281.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-207281 Ophthalmic Solution | Mean Concentration of AGN-207281 in Plasma at Day 14 | 540 Picograms per milliliter (pg/mL) | Standard Deviation 263 |
Secondary
Mean Concentration of AGN-207281 in Plasma at Day 7
Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Time frame: Day 7
Population: The analysis population included all patients that started the study and were treated with AGN-207281.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AGN-207281 Ophthalmic Solution | Mean Concentration of AGN-207281 in Plasma at Day 7 | 177 Picograms per milliliter (pg/mL) | Standard Deviation 113 |