Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07218796 | Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone) | PHASE3 | RECRUITING | 400 | — | — | Oct 28, 2025 | May 31, 2031 | Oct 20, 2025 | 1 | United States |
| NCT07218783 | Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine) | PHASE3 | RECRUITING | 400 | — | — | Oct 15, 2025 | Mar 31, 2031 | Oct 20, 2025 | 1 | United States |
| NCT06120842 | Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution | PHASE1 | ACTIVE NOT_RECRUITING | 201 | — | — | Oct 13, 2023 | Nov 1, 2027 | Aug 22, 2025 | 1 | United States |
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
| Arm | Type | Description |
|---|---|---|
| Bimatoprost Implant System / IOL Combination | EXPERIMENTAL | - |
| Timolol Maleate Ophthalmic Solution 0.5% | ACTIVE_COMPARATOR | - |
| Bimatoprost Implant System (High Dose) / IOL Combination | EXPERIMENTAL | - |
| Bimatoprost Implant System (Low Dose) / IOL Combination | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bimatoprost Implant System | DRUG | Bimatoprost Implant System used in combination with the SpyGlass IOL |
| 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 |
| Bimatoprost Implant System (High Dose) | DRUG | Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL |
| Bimatoprost Implant System (Low Dose) | DRUG | Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL |
| Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL | DEVICE | Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens |
Inclusion Criteria: * Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension * Planned removal of cataract * Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception Exclusion Criteria: * ...