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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Experimental | Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months. |
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| Timolol 0.5% + Placebo Ocular Insert | Active Comparator | Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Bimatoprost ocular insert |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) to Week 2 |
| 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. | Baseline (Day 0) to Week 6 |
| 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. | Baseline (Day 0) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Month 4 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Chen, PhD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Medical Research Center | Artesia | California | 90701 | United States | ||
| Scripps Clinic Torrey Pines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35076329 | Derived | Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Washout + Placebo Ocular Insert | Glaucoma medication washout and placebo ocular insert in each eye for at least 4 weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-randomization Washout Period |
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| Timolol 0.5% |
| Drug |
Timolol 0.5% solution |
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| Placebo Eye Drops | Drug | Placebo topical eye drops |
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| Placebo Ocular Insert | Device | Ocular insert without any active drug |
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| 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. | Baseline (Day 0) to Month 5 |
| 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. | Baseline (Day 0) to Month 6 |
| La Jolla |
| California |
| 92037 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| UC Davis Dept of Ophthalmology & Vision Science | Sacramento | California | 95817 | United States |
| Coastal Research Associates | Atlanta | Georgia | 30076 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Ophthalmology Consultants | St Louis | Missouri | 63131 | United States |
| UNC Kittner Eye Center | Chapel Hill | North Carolina | 27517 | United States |
| Apex Eye | Madeira | Ohio | 45243 | United States |
| Ophthalmology Associates PC | Fort Worth | Texas | 76102 | United States |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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Safety population included all randomized participants who had ocular inserts placed in their eyes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 0) to Week 2 |
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| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 0) to Week 6 |
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| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 0) to Week 12 |
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| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 1) to Month 4 |
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| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 0) to Month 5 |
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| 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. | 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. | Posted | Mean | Standard Error | mm Hg | Baseline (Day 0) to Month 6 |
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Randomization (Day 0) to the end of study (Up to 6 Months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 64 | 20 | 64 | ||
| EG001 | 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. | 2 | 66 | 14 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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| Other Miscellaneous Reasons |
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| Male |
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| Baseline (T=2 hour) |
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| Baseline (T=8 hour) |
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| Change from Baseline to Week 2 (T=0 hour) |
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| Change from Baseline to Week 2 (T=2 hour) |
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| Change from Baseline to Week 2 (T=8 hour) |
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