Primary Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension
Brief summary
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
Interventions
DRUGBimatoprost
Bimatoprost ocular insert
DRUGTimolol 0.5%
Timolol 0.5% solution
Placebo topical eye drops
DEVICEPlacebo Ocular Insert
Ocular insert without any active drug
Sponsors
ForSight Vision5, Inc.
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
Key Inclusion Criteria: * Written informed consent * Primary open-angle glaucoma or ocular hypertension in both eyes * Best-corrected distance vision of 20/80 or better * Stable visual field * corneal thickness between 490-620 micrometers Key
Exclusion criteria
* Cup-to-disc ratio greater than 0.8 * significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy * laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months * past history of corneal refractive surgery * past history of any incisional surgery for glaucoma at any time * corneal abnormalities that would interfere with tonometry readings * current participation in an investigational drug or device study or participation in such a study within 30 days of screening * Inability to accurately evaluate the retina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (Day 0) to Week 2 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
| Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (Day 0) to Week 6 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
| Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (Day 0) to Week 12 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in IOP at Month 4 | Baseline (Day 1) to Month 4 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
| Change From Baseline in IOP at Month 5 | Baseline (Day 0) to Month 5 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
| Change From Baseline in IOP at Month 6 | Baseline (Day 0) to Month 6 | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13 mg Bimatoprost Ocular Insert Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months. | 64 |
| Timolol 0.5% + Placebo Ocular Insert Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months. | 66 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Pre-randomization Washout Period | Not Qualified for Randomization | 39 | 0 | 0 |
| Treatment Period | Adverse Event | 0 | 9 | 1 |
| Treatment Period | Decision of Participant | 0 | 1 | 3 |
| Treatment Period | Other Miscellaneous Reasons | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 13 mg Bimatoprost Ocular Insert | Timolol 0.5% + Placebo Ocular Insert | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 10.1 | 66.3 years STANDARD_DEVIATION 8.5 | 65.6 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 33 Participants | 44 Participants | 77 Participants |
| Sex: Female, Male Male | 31 Participants | 22 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 64 | 14 / 66 |
| serious Total, serious adverse events | 1 / 64 | 2 / 66 |
Outcome results
Primary
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 12
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=0 hour) | -5.26 mm Hg | Standard Error 0.47 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=2 hour) | -4.26 mm Hg | Standard Error 0.44 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=8 hour) | -3.99 mm Hg | Standard Error 0.33 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=2 hour) | -5.60 mm Hg | Standard Error 0.43 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=0 hour) | -6.31 mm Hg | Standard Error 0.43 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Change from Baseline to Week 12 (T=8 hour) | -5.19 mm Hg | Standard Error 0.35 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
Primary
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 2
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=0 hour) | -6.40 mm Hg | Standard Error 0.41 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=2 hour) | -5.20 mm Hg | Standard Error 0.34 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=8 hour) | -4.21 mm Hg | Standard Error 0.35 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=2 hour) | -5.59 mm Hg | Standard Error 0.41 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=0 hour) | -6.30 mm Hg | Standard Error 0.41 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Change from Baseline to Week 2 (T=8 hour) | -4.96 mm Hg | Standard Error 0.37 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
Primary
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 6
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=0 hour) | -5.47 mm Hg | Standard Error 0.4 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=2 hour) | -4.70 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=8 hour) | -3.78 mm Hg | Standard Error 0.34 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=2 hour) | -5.40 mm Hg | Standard Error 0.39 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=0 hour) | -6.41 mm Hg | Standard Error 0.41 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Change from Baseline to Week 6 (T=8 hour) | -4.42 mm Hg | Standard Error 0.39 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
Secondary
Change From Baseline in IOP at Month 4
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 1) to Month 4
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=0 hour) | -5.14 mm Hg | Standard Error 0.43 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=2 hour) | -4.37 mm Hg | Standard Error 0.38 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=8 hour) | -3.84 mm Hg | Standard Error 0.34 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=2 hour) | -5.26 mm Hg | Standard Error 0.41 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=0 hour) | -6.29 mm Hg | Standard Error 0.4 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Change from Baseline to Month 4 (T=8 hour) | -5.11 mm Hg | Standard Error 0.36 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 4 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
Secondary
Change From Baseline in IOP at Month 5
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 0) to Month 5
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T= 2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=0 hour) | -4.28 mm Hg | Standard Error 0.36 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=2 hour) | -3.87 mm Hg | Standard Error 0.39 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=8 hour) | -3.21 mm Hg | Standard Error 0.34 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=2 hour) | -5.45 mm Hg | Standard Error 0.43 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=0 hour) | -6.35 mm Hg | Standard Error 0.41 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T= 2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Change from Baseline to Month 5 (T=8 hour) | -4.47 mm Hg | Standard Error 0.38 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 5 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
Secondary
Change From Baseline in IOP at Month 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Time frame: Baseline (Day 0) to Month 6
Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=2 hour) | 23.65 mm Hg | Standard Error 0.31 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=0 hour) | -4.58 mm Hg | Standard Error 0.39 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=0 hour) | 24.99 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=2 hour) | -3.87 mm Hg | Standard Error 0.42 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=8 hour) | 22.95 mm Hg | Standard Error 0.29 |
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=8 hour) | -3.25 mm Hg | Standard Error 0.32 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=8 hour) | -4.24 mm Hg | Standard Error 0.37 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=0 hour) | 25.34 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=2 hour) | 23.75 mm Hg | Standard Error 0.28 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Baseline (T=8 hour) | 23.16 mm Hg | Standard Error 0.29 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=0 hour) | -5.97 mm Hg | Standard Error 0.42 |
| Timolol 0.5% + Placebo Ocular Insert | Change From Baseline in IOP at Month 6 | Change from Baseline to Month 6 (T=2 hour) | -5.20 mm Hg | Standard Error 0.41 |