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This trial is a randomized study to evaluate 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 / IOL Combination | Experimental |
| |
| Timolol Maleate Ophthalmic Solution 0.5% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost Implant System | Drug | Bimatoprost Implant System used in combination with the SpyGlass IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP Reduction from Baseline (mmHg) | Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints | Weeks 2 and 6, and Month 3 |
| BCDVA 20/40 or better | Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better | Month 6 |
| 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 | Month 6, 9 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Contact | 949-284-6904 | clinical@spyglasspharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Yoo, OD | SpyGlass Pharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R and R Eye Research, LLC | Recruiting | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| SpyGlass Pharma Website | View source |
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| SpyGlass IOL | Device | SpyGlass Intraocular Lens |
|
| Timolol Maleate Ophthalmic Solution, 0.5% | Drug | Timolol Maleate Ophthalmic Solution, 0.5% BID |
|
| Commercial IOL | Device | Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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