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This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Implant System (High Dose) / IOL Combination | Experimental |
| |
| Bimatoprost Implant System (Low Dose) / IOL Combination | Experimental |
| |
| Timolol Maleate Ophthalmic Solution 0.5% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Implant System (High Dose) | Drug | Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP Reduction from Baseline (mmHg) | Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints | Weeks 2 and 6, and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP | Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 | Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 |
| Mean IOP Change from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Rates of Adverse Events | Total Study Period of 36 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Hafner | SpyGlass Pharma, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advanced Eye Research Institute | Glendale | Arizona | 85306 | United States |
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| Label | URL |
|---|---|
| SpyGlass Pharma Website | View source |
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| Bimatoprost Implant System (Low Dose) | Drug | Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL |
|
| Timolol Maleate Ophthalmic Solution, 0.5% | Drug | Timolol Maleate Ophthalmic Solution 0.5% BID |
|
| Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL | Device | Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens |
|
| SpyGlass IOL | Device | SpyGlass Intraocular Lens |
|
Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36
| Months 6, 12, 18, 24, 27, 30, 33, and 36 |
| Time to postoperative introduction of IOP-lowering medications | Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments) | Total Study Period of 36 Months |
| Number of IOP-lowering medications introduced postoperatively | Number of IOP-lowering medications introduced postoperatively (N) at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36 | Total Study Period of 36 Months |
| Proportion of eyes achieving BCDVA 20/40 or better | Snellen Equivalent | Months 3, 6, and 12 |
| Manifest refraction spherical equivalent | Manifest refraction spherical equivalent (MRSE) | Month 3 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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