Primary Open-Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension. This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).
Interventions
DRUGBimatoprost
Bimatoprost sustained release Ocular Insert
DRUGTimolol 0.5%
BID drops OU, 0.5% ophthalmic solution
DEVICEPlacebo Ocular Insert
Placebo ocular insert OU.
Placebo eye drops BID OU.
Sponsors
ForSight Vision5, Inc.
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
Key Inclusion Criteria: * Written informed consent * At least 18 years of age * Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension * Best corrected-distance visual acuity score equivalent to 20/80 or better * Stable visual field * Central corneal thickness between 490 - 620 micrometers Inclusion Criteria at the Randomization Visit: (T is defined as time and hr is defined as hour\[s\]) * IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr. * Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr. * IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr. Key
Exclusion criteria
* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol * A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops * Cup-to-disc ratio of 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 * Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date * Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months * Past history of any incisional surgery for glaucoma at any time * Past history of corneal refractive surgery * Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer * Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening * Inability to adequately evaluate the retina * Participants who will require contact lens use during the study period. * Participants who currently have punctal occlusion * Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Week 12 to Week 24 | 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. |
| Dilated Fundus Exam: Cup-to-Disc-Ratio | Week 12 | 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. |
| Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | 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. |
| Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Baseline (Day 0) to Week 12 | 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. |
| Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Baseline (Day 0) to 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. |
| Change From Baseline in 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 an improvement. |
| Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Baseline (Day 0) to 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. |
| Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Baseline (Day 0) to 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. |
| Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12 | Baseline (Day 0) to 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. |
| Change From Baseline in Automated Visual Field at Week 12 | Baseline (Day 0) to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 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 an improvement. |
| Change From Baseline in IOP in Period C | Baseline (Day 0) to Weeks 14, 18 and 24 | 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. |
| Change From Baseline in 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 (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. |
Countries
United States
Participant flow
Pre-assignment details
156 participants were enrolled and entered the washout placebo and trial-wear period. A total of 121 participants were randomized to one of three treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Ocular Insert + Timolol 0.5% Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts 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. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks. | 40 |
| 2.2 mg Bimatoprost Ocular Insert 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. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks. | 40 |
| 13 mg Bimatoprost Ocular Insert Following the washout period, 13 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 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks. | 41 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Pre-Randomization Washout Period | Not Qualified for Randomization | 35 | 0 | 0 | 0 | 0 |
| Treatment Period A/B | Adverse Event | 0 | 0 | 1 | 2 | 0 |
| Treatment Period A/B | Death | 0 | 0 | 1 | 0 | 0 |
| Treatment Period A/B | Withdrawal by Subject | 0 | 2 | 0 | 2 | 0 |
| Treatment Period C | Adverse Event | 0 | 0 | 0 | 0 | 7 |
Baseline characteristics
| Characteristic | Placebo Ocular Insert + Timolol 0.5% | 2.2 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert | Total |
|---|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 8.7 | 64.1 years STANDARD_DEVIATION 9.24 | 63.0 years STANDARD_DEVIATION 10.01 | 64.9 years STANDARD_DEVIATION 9.47 |
| Sex: Female, Male Female | 27 Participants | 20 Participants | 35 Participants | 82 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 6 Participants | 39 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 | 9 / 156 | 16 / 40 | 12 / 40 | 20 / 41 |
| serious Total, serious adverse events | 0 / 156 | 3 / 40 | 1 / 40 | 1 / 41 |
Outcome results
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.
Time frame: Baseline (Day 0) to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Baseline | -2.58 decibels (dB) | Standard Deviation 3.377 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Change from Baseline to Week 12 | -0.18 decibels (dB) | Standard Deviation 2.01 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Baseline | -1.45 decibels (dB) | Standard Deviation 4.041 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Change from Baseline to Week 12 | 0.02 decibels (dB) | Standard Deviation 1.819 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Baseline | -2.70 decibels (dB) | Standard Deviation 2.934 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Automated Visual Field at Week 12 | Change from Baseline to Week 12 | 0.39 decibels (dB) | Standard Deviation 1.446 |
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.
Time frame: Baseline (Day 0) to Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=2 hour) | -3.62 mm Hg | Standard Deviation 2.924 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=0 hour) | -4.68 mm Hg | Standard Deviation 2.931 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=8 hour) | -3.21 mm Hg | Standard Deviation 2.812 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=2 hour) | -3.31 mm Hg | Standard Deviation 3.063 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=0 hour) | -3.68 mm Hg | Standard Deviation 3.105 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=8 hour) | -3.23 mm Hg | Standard Deviation 2.573 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=0 hour) | -4.56 mm Hg | Standard Deviation 3.007 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=8 hour) | -3.22 mm Hg | Standard Deviation 3.061 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in Intraocular Pressure (IOP) at Week 8 | Change from Baseline to Week 8 (T=2 hour) | -3.98 mm Hg | Standard Deviation 3.522 |
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.
Time frame: Baseline (Day 0) to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=0 hour) | -3.37 mm Hg | Standard Deviation 3.147 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=8 hour) | -2.34 mm Hg | Standard Deviation 2.756 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=2 hour) | -2.74 mm Hg | Standard Deviation 2.891 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=0 hour) | -3.64 mm Hg | Standard Deviation 3.454 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=8 hour) | -3.20 mm Hg | Standard Deviation 2.491 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=2 hour) | -3.67 mm Hg | Standard Deviation 3.182 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=8 hour) | -2.69 mm Hg | Standard Deviation 2.523 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=2 hour) | -3.40 mm Hg | Standard Deviation 3.815 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 12 | Change from Baseline to Week 12 (T=0 hour) | -4.08 mm Hg | Standard Deviation 2.893 |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Right Eye, Week 12 | 0.53 ratio | Standard Deviation 0.172 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Left Eye, Week 12 | 0.54 ratio | Standard Deviation 0.16 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Left Eye, Week 12 | 0.56 ratio | Standard Deviation 0.157 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Right Eye, Week 12 | 0.55 ratio | Standard Deviation 0.161 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Left Eye, Week 12 | 0.48 ratio | Standard Deviation 0.176 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Dilated Fundus Exam: Cup-to-Disc-Ratio | Right Eye, Week 12 | 0.47 ratio | Standard Deviation 0.184 |
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.
Time frame: Baseline (Day 0) to Week 12
Population: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10+ Letter Improvement | 0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5+ Letter Improvement | 7.9 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, No Change | 73.7 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5- Letter Worsening | 13.2 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10- Letter Worsening | 5.3 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5+ Letter Improvement | 7.9 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5- Letter Worsening | 18.4 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10- Letter Worsening | 2.6 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, No Change | 71.1 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10+ Letter Improvement | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5- Letter Worsening | 28.9 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5- Letter Worsening | 15.8 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10- Letter Worsening | 7.9 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5+ Letter Improvement | 13.2 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, No Change | 68.4 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10+ Letter Improvement | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5+ Letter Improvement | 5.3 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10- Letter Worsening | 2.6 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, No Change | 57.9 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10+ Letter Improvement | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10- Letter Worsening | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5- Letter Worsening | 22.2 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 5+ Letter Improvement | 11.1 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10+ Letter Improvement | 2.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 10+ Letter Improvement | 5.6 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5- Letter Worsening | 13.9 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, 10- Letter Worsening | 2.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, 5+ Letter Improvement | 19.4 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Right Eye, No Change | 61.1 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12 | Left Eye, No Change | 61.1 percentage of participants |
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.
Time frame: Baseline (Day 0) to Week 8
Population: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10+ Letter Improvement | 2.6 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5+ Letter Improvement | 18.4 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5- Letter Worsening | 13.2 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10- Letter Worsening | 0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, No Change | 68.4 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5- Letter Worsening | 15.8 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10- Letter Worsening | 2.6 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, No Change | 65.8 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10+ Letter Improvement | 2.6 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5+ Letter Improvement | 10.5 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10- Letter Worsening | 5.1 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10+ Letter Improvement | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5- Letter Worsening | 7.7 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10- Letter Worsening | 5.1 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5+ Letter Improvement | 20.5 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10+ Letter Improvement | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5- Letter Worsening | 17.9 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5+ Letter Improvement | 7.7 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, No Change | 69.2 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, No Change | 66.7 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5+ Letter Improvement | 19.4 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, No Change | 77.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10+ Letter Improvement | 5.6 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10- Letter Worsening | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 5- Letter Worsening | 5.6 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, No Change | 66.7 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5- Letter Worsening | 13.9 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Left Eye, 10- Letter Worsening | 2.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 10+ Letter Improvement | 2.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8 | Right Eye, 5+ Letter Improvement | 5.6 percentage of participants |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, None | 63.2 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Mild | 34.2 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Moderate | 2.7 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, None | 62.2 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Mild | 35.1 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Moderate | 2.6 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Mild | 26.3 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, None | 71.1 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Moderate | 2.6 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Moderate | 2.6 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, None | 71.1 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Mild | 26.3 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, None | 47.2 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Moderate | 5.6 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, None | 50.0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Right Eye, Mild | 44.4 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Moderate | 2.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12 | Left Eye, Mild | 50.0 percentage of participants |
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.
Time frame: Baseline (Day 0) to Week 12
Population: Safety population included all participants who had an ocular insert placed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12 | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12 | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12 | 0 percentage of participants |
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.
Time frame: Baseline (Day 0) to Week 12
Population: Safety Population included all randomized participants who had an ocular insert placed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Moderate | 2.5 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-Ocular, Moderate | 15.0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Mild | 5.0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Mild | 12.5 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Severe | 0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Severe | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Mild | 5.0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Moderate | 5.0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Severe | 0 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-Ocular, Moderate | 2.5 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Severe | 2.5 percentage of participants |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Mild | 17.5 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-Ocular, Moderate | 7.3 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Moderate | 4.9 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Mild | 26.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Mild | 9.8 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Ocular, Severe | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B | Non-ocular, Severe | 0 percentage of participants |
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.
Time frame: Week 12 to Week 24
Population: Safety Population included all randomized participants who had an ocular insert placed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Ocular, Mild | 23.9 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Ocular, Moderate | 5.3 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Ocular, Severe | 0 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Non-ocular, Mild | 5.3 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Non-ocular, Moderate | 4.4 percentage of participants |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C | Non-ocular, Severe | 0.9 percentage of participants |
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.
Time frame: Baseline (Day 0) to Week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=2 hour) | -5.71 mm Hg | Standard Deviation 2.277 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=0 hour) | -6.84 mm Hg | Standard Deviation 2.264 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=8 hour) | -4.81 mm Hg | Standard Deviation 2.612 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=2 hour) | -4.14 mm Hg | Standard Deviation 2.637 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=0 hour) | -4.56 mm Hg | Standard Deviation 3.134 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=8 hour) | -3.76 mm Hg | Standard Deviation 2.32 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=0 hour) | -5.95 mm Hg | Standard Deviation 2.367 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=8 hour) | -4.52 mm Hg | Standard Deviation 2.594 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 2 | Change from Baseline to Week 2 (T=2 hour) | -5.34 mm Hg | Standard Deviation 2.499 |
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.
Time frame: Baseline (Day 0) to Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=0 hour) | -6.42 mm Hg | Standard Deviation 2.77 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=8 hour) | -4.40 mm Hg | Standard Deviation 2.529 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=2 hour) | -4.97 mm Hg | Standard Deviation 2.948 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=0 hour) | -4.87 mm Hg | Standard Deviation 3.212 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=2 hour) | -4.40 mm Hg | Standard Deviation 3.138 |
| 2.2 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=8 hour) | -3.73 mm Hg | Standard Deviation 2.393 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=8 hour) | -3.77 mm Hg | Standard Deviation 2.291 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=2 hour) | -4.42 mm Hg | Standard Deviation 2.83 |
| 13 mg Bimatoprost Ocular Insert (Period A/B) | Change From Baseline in IOP at Week 6 | Change from Baseline to Week 6 (T=0 hour) | -5.30 mm Hg | Standard Deviation 2.941 |
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.
Time frame: Baseline (Day 0) to Weeks 14, 18 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 14 (T=0 hour) | -5.72 mm Hg | Standard Deviation 2.919 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 14 (T=2 hour) | -4.64 mm Hg | Standard Deviation 3.1 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 14 (T=8 hour) | -4.13 mm Hg | Standard Deviation 2.849 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 18 (T=0 hour) | -5.62 mm Hg | Standard Deviation 3.135 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 18 (T=2 hour) | -4.33 mm Hg | Standard Deviation 3.072 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 18 (T=8 hour) | -4.17 mm Hg | Standard Deviation 2.714 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 24 (T=0 hour) | -4.85 mm Hg | Standard Deviation 2.882 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 24 (T=2 hour) | -3.99 mm Hg | Standard Deviation 2.847 |
| Placebo Ocular Insert + Timolol 0.5% (Period A/B) | Change From Baseline in IOP in Period C | Change from Baseline to Week 24 (T=8 hour) | -2.99 mm Hg | Standard Deviation 3.01 |