Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).
Interventions
DRUGAGN-210669 ophthalmic solution, 0.1%
One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
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 * Patient requires IOP lowering medication in each eye
Exclusion criteria
* Ocular hyperemia or other ocular surface findings in either eye * Active ocular disease * Current or anticipated use of any topical ocular medication (including artificial tears) during the study * Intraocular surgery within past six months or unilateral cataract surgery. * Functionally significant visual field loss * Anticipated wearing of contact lenses during study * Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline, Day 29 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-210669 Ophthalmic Solution, 0.1% One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. | 39 |
| AGN-210669 Ophthalmic Solution, 0.075% One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. | 41 |
| AGN-210669 Ophthalmic Solution, 0.05% One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. | 44 |
| Bimatoprost Ophthalmic Solution 0.03% One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. | 41 |
| Total | 165 |
Baseline characteristics
| Characteristic | Total | AGN-210669 Ophthalmic Solution, 0.1% | AGN-210669 Ophthalmic Solution, 0.075% | AGN-210669 Ophthalmic Solution, 0.05% | Bimatoprost Ophthalmic Solution 0.03% |
|---|---|---|---|---|---|
| Age, Customized 45 to 65 years | 88 Participants | 22 Participants | 24 Participants | 21 Participants | 21 Participants |
| Age, Customized <45 years | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Age, Customized >65 years | 73 Participants | 16 Participants | 16 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Female | 87 Participants | 24 Participants | 22 Participants | 23 Participants | 18 Participants |
| Sex: Female, Male Male | 78 Participants | 15 Participants | 19 Participants | 21 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 39 | 35 / 41 | 23 / 44 | 29 / 41 |
| serious Total, serious adverse events | 1 / 39 | 0 / 41 | 0 / 44 | 0 / 41 |
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 29 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, 0.1% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.88 Millimeters of Mercury (mmHg) | Standard Deviation 3.696 |
| AGN-210669 Ophthalmic Solution, 0.1% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 0 | -7.50 Millimeters of Mercury (mmHg) | Standard Deviation 4.219 |
| AGN-210669 Ophthalmic Solution, 0.075% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 0 | -7.65 Millimeters of Mercury (mmHg) | Standard Deviation 3.171 |
| AGN-210669 Ophthalmic Solution, 0.075% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.18 Millimeters of Mercury (mmHg) | Standard Deviation 2.382 |
| AGN-210669 Ophthalmic Solution, 0.05% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.39 Millimeters of Mercury (mmHg) | Standard Deviation 2.77 |
| AGN-210669 Ophthalmic Solution, 0.05% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 0 | -5.66 Millimeters of Mercury (mmHg) | Standard Deviation 3.082 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Baseline - Hour 0 | 25.73 Millimeters of Mercury (mmHg) | Standard Deviation 3.49 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Average Eye Intraocular Pressure (IOP) | Change from Baseline at Day 29 - Hour 0 | -8.57 Millimeters of Mercury (mmHg) | Standard Deviation 3.854 |