| Primary | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | 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 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. | Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 8. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Day 0) to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 | 13 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops to each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. |
| | | Title | Denominators | Categories |
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| Change from Baseline to Week 8 (T=0 hour) | | | Title | Measurements |
|---|
| - OG000-4.68± 2.931
- OG001-3.68± 3.105
- OG002-4.56± 3.007
|
| | Change from Baseline to Week 8 (T=2 hour) |
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| Primary | Change From Baseline in 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 an improvement. | FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 12. Participants on rescue therapy with missing data during the evaluation period or measurements out of the pre-specified visit window had IOP data imputed using LOCF (last observation carried forward) for the visit. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. |
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| Primary | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 8. | Posted | | Number | | percentage of participants | | Baseline (Day 0) to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | |
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| Primary | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 12. | Posted | | Number | | percentage of participants | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | |
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| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12 | The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination. | Safety population included all participants who had an ocular insert placed. | Posted | | Number | | percentage of participants | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 | 13 mg Bimatoprost Ocular Insert (Period A/B) |
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| Primary | Change From Baseline in Automated Visual Field at Week 12 | Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement. | Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point. | Posted | | Mean | Standard Deviation | decibels (dB) | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 |
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| Primary | Dilated Fundus Exam: Cup-to-Disc-Ratio | The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma. | Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis. The number analyzed is the number of participants with data available at the given time-point. | Posted | | Mean | Standard Deviation | ratio | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 |
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| Primary | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported. | Safety Population included all randomized participants who had an ocular insert placed. The number of participants analyzed is the number of participants with data available at the given time-point. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 | 13 mg Bimatoprost Ocular Insert (Period A/B) |
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| Primary | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. | Safety Population included all randomized participants who had an ocular insert placed. | Posted | | Number | | percentage of participants | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. |
|
| Primary | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. | Safety Population included all randomized participants who had an ocular insert placed. | Posted | | Number | | percentage of participants | | Week 12 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 13 mg Bimatoprost Ocular Insert (Period C) | Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks in Period C (Week 12 to Week 24). |
| |
| Secondary | Change From Baseline in IOP at Week 2 | 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 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. | Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 2. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Day 0) to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 |
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| Secondary | Change From Baseline in 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 an improvement. | Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 6. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Day 0) to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular insert in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. | | OG001 | 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. | | OG002 |
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| Secondary | Change From Baseline in IOP in Period C | 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 Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. | Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at the given timepoint. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Day 0) to Weeks 14, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 13 mg Bimatoprost Ocular Insert (Period C) | Following Treatment Period A/B, 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks in Period C (Week 12 to Week 24). |
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