Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.
Interventions
DRUGAGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
DRUGbimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye * Requires bilateral treatment with an IOP-lowering medication * Best corrected visual acuity of 20/100 or better in each eye
Exclusion criteria
* Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months * Inability to fast for up to 10 hours * Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy) * Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months * Current or anticipated use of artificial tears or any ocular medications aside from study medications during study * Anticipated wearing of contact lenses during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Eye IOP | Baseline, Day 57 | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Worse Eye IOP | Baseline, Day 57 | IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12. |
Countries
United States
Participant flow
Pre-assignment details
Pts were randomized at Baseline for the entire study. At Mo 1, pts received either AGN-210669 or bimatoprost. At Mo 2, pts who had received AGN-210669, then received either AGN-210669+bimatoprost or AGN-210669+bimatoprost vehicle and pts who had received bimatoprost, then received either bimatoprost+AGN-210669 or bimatoprost+bimatoprost vehicle.
Participants by arm
| Arm | Count |
|---|---|
| AGN-210669 Followed by AGN-210669 + Bimatoprost AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2. | 44 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2. | 21 |
| Bimatoprost Followed by Bimatoprost + AGN-210669 bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2. | 40 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2. | 20 |
| Total | 125 |
Baseline characteristics
| Characteristic | Total | AGN-210669 Followed by AGN-210669 + Bimatoprost | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Bimatoprost Followed by Bimatoprost + AGN-210669 | Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle |
|---|---|---|---|---|---|
| Age, Customized 45 to 65 years | 54 Participants | 17 Participants | 10 Participants | 20 Participants | 7 Participants |
| Age, Customized <45 years | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized >65 years | 68 Participants | 26 Participants | 10 Participants | 19 Participants | 13 Participants |
| Sex: Female, Male Female | 82 Participants | 27 Participants | 15 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 43 Participants | 17 Participants | 6 Participants | 13 Participants | 7 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 65 | 31 / 40 | 11 / 24 | 41 / 60 | 26 / 34 | 15 / 26 |
| serious Total, serious adverse events | 0 / 65 | 0 / 40 | 0 / 24 | 0 / 60 | 0 / 34 | 1 / 26 |
Outcome results
Primary
Change From Baseline in Average Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12.
Time frame: Baseline, Day 57
Population: Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -5.31 Millimeters of Mercury (mmHg) | Standard Deviation 2.69 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -7.57 Millimeters of Mercury (mmHg) | Standard Deviation 2.881 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 0 | 26.16 Millimeters of Mercury (mmHg) | Standard Deviation 2.169 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -5.57 Millimeters of Mercury (mmHg) | Standard Deviation 3.484 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -6.95 Millimeters of Mercury (mmHg) | Standard Deviation 2.503 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 12 | 21.48 Millimeters of Mercury (mmHg) | Standard Deviation 2.467 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 8 | 22.49 Millimeters of Mercury (mmHg) | Standard Deviation 1.338 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 4 | 23.91 Millimeters of Mercury (mmHg) | Standard Deviation 2.382 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -7.19 Millimeters of Mercury (mmHg) | Standard Deviation 3.198 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 0 | 25.98 Millimeters of Mercury (mmHg) | Standard Deviation 1.962 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 4 | 23.82 Millimeters of Mercury (mmHg) | Standard Deviation 2.301 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 8 | 22.35 Millimeters of Mercury (mmHg) | Standard Deviation 2.024 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -6.87 Millimeters of Mercury (mmHg) | Standard Deviation 2.838 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Baseline - Hour 12 | 22.07 Millimeters of Mercury (mmHg) | Standard Deviation 2.596 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -10.28 Millimeters of Mercury (mmHg) | Standard Deviation 3.19 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -8.95 Millimeters of Mercury (mmHg) | Standard Deviation 3.531 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Baseline - Hour 8 | 22.79 Millimeters of Mercury (mmHg) | Standard Deviation 2.391 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Baseline - Hour 4 | 23.85 Millimeters of Mercury (mmHg) | Standard Deviation 2.553 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Baseline - Hour 0 | 26.26 Millimeters of Mercury (mmHg) | Standard Deviation 2.446 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -7.67 Millimeters of Mercury (mmHg) | Standard Deviation 2.596 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -8.79 Millimeters of Mercury (mmHg) | Standard Deviation 3.33 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Baseline - Hour 12 | 21.73 Millimeters of Mercury (mmHg) | Standard Deviation 2.624 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -10.84 Millimeters of Mercury (mmHg) | Standard Deviation 3.46 |
| Combined Adjunctives | Change From Baseline in Average Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -6.03 Millimeters of Mercury (mmHg) | Standard Deviation 2.642 |
Secondary
Change From Baseline in Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12.
Time frame: Baseline, Day 57
Population: Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 12 | 21.72 Millimeters of Mercury (mmHg) | Standard Deviation 2.811 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 0 | 26.56 Millimeters of Mercury (mmHg) | Standard Deviation 2.305 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -5.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.696 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -7.38 Millimeters of Mercury (mmHg) | Standard Deviation 2.841 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -7.50 Millimeters of Mercury (mmHg) | Standard Deviation 2.989 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -5.94 Millimeters of Mercury (mmHg) | Standard Deviation 3.817 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 8 | 23.04 Millimeters of Mercury (mmHg) | Standard Deviation 1.687 |
| AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 4 | 24.60 Millimeters of Mercury (mmHg) | Standard Deviation 2.754 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -7.42 Millimeters of Mercury (mmHg) | Standard Deviation 3.526 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 0 | 26.40 Millimeters of Mercury (mmHg) | Standard Deviation 2.069 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 4 | 24.25 Millimeters of Mercury (mmHg) | Standard Deviation 2.295 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 8 | 22.73 Millimeters of Mercury (mmHg) | Standard Deviation 2.29 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -10.56 Millimeters of Mercury (mmHg) | Standard Deviation 3.435 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -9.16 Millimeters of Mercury (mmHg) | Standard Deviation 3.472 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -7.00 Millimeters of Mercury (mmHg) | Standard Deviation 2.969 |
| Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Change From Baseline in Worse Eye IOP | Baseline - Hour 12 | 22.47 Millimeters of Mercury (mmHg) | Standard Deviation 2.598 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 0 (n=24,25,72) | -10.96 Millimeters of Mercury (mmHg) | Standard Deviation 3.705 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Baseline - Hour 4 | 24.31 Millimeters of Mercury (mmHg) | Standard Deviation 2.685 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 12 (n=16,17,56) | -5.99 Millimeters of Mercury (mmHg) | Standard Deviation 3.076 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Baseline - Hour 8 | 23.17 Millimeters of Mercury (mmHg) | Standard Deviation 2.591 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Baseline - Hour 0 | 26.61 Millimeters of Mercury (mmHg) | Standard Deviation 2.664 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Baseline - Hour 12 | 21.93 Millimeters of Mercury (mmHg) | Standard Deviation 2.908 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 4 (n=24,25,72) | -9.01 Millimeters of Mercury (mmHg) | Standard Deviation 3.515 |
| Combined Adjunctives | Change From Baseline in Worse Eye IOP | Change from Baseline at Day 57-Hr 8 (n=24,25,72) | -7.92 Millimeters of Mercury (mmHg) | Standard Deviation 3.002 |