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The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:
Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?
Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental |
| |
| Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL | Experimental |
| |
| Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental |
| |
| Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug)) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIM-DRS Low Dose | Drug | Bimatoprost-Drug Ring System Low Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP change from Baseline (mmHg) | Postoperative Week 2, Week 6, and Month 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP (mmHg) | Postoperative Week 2, Week 6, and Months 3, 6, 12, 18, 24, 30, and 36 | |
| Mean IOP change from Baseline (mmHg) | Postoperative Months 6, 12, 18, 24, 30, and 36 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr. Vice President, Clinical Development | Contact | 949-284-6904 | clinical@spyglasspharma.com |
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| Label | URL |
|---|---|
| SpyGlass Pharma Website | View source |
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To minimize bias, IOP will be measured by 2 observers - one observer will perform measurements (unmasked to treatment), while the second observer will record the measurements (masked to treatment)
| BIM-DRS High Dose | Drug | Bimatoprost-Drug Ring System High Dose |
|
| SpyGlass IOL with silicone pads (no drug) | Device | SpyGlass Intraocular Lens with silicone pads (no drug) |
|
| Mean IOP change from Baseline |
| Postoperative Months 6, 12, 18, 24, 30, and 36 |
| Time to postoperative introduction of additional IOP-lowering medication | Postoperative Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 |
| Number of additional IOP-lowering medications introduced | Postoperative Months 3, 6, 12, 18, 24, 30, and 36 |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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