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Bimatoprost System

Phase 3

Cataract | Small molecule | Ophthalmology |SpyGlass Pharma, Inc.|Last Updated: Oct 20, 2025

Success Probability
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials3
Total Enrollment1,001
FDA Designations
No designations recorded
Clinical trial landscape

Bimatoprost System · 3 trials · 3 indications

Phase 3 2Phase 1 1
NCT07218796Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)Cataract
RECRUITING400 Analytics
NCT07218783Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)Cataract
RECRUITING400 Analytics
PHASE3RECRUITING
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
Cataract
NCT07218796400
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PHASE3RECRUITING
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
Cataract
NCT07218783400
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Study Endpoints
Primary Endpoints
Mean IOP Reduction from Baseline (mmHg)
Weeks 2 and 6, and Month 3

Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints

BCDVA 20/40 or better
Month 6

Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better

Secondary Endpoints
Mean IOP Reduction from Baseline (mmHg)
Month 6, 9 and 12
Mean IOP
Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Mean IOP Change from Baseline
Months 6, 12, 18, 24, 27, 30, 33, and 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bimatoprost Implant System / IOL CombinationEXPERIMENTAL -
Timolol Maleate Ophthalmic Solution 0.5%ACTIVE_COMPARATOR -
Bimatoprost Implant System (High Dose) / IOL CombinationEXPERIMENTAL -
Bimatoprost Implant System (Low Dose) / IOL CombinationEXPERIMENTAL -
Interventions
NameTypeDescription
Bimatoprost Implant SystemDRUGBimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass IOLDEVICESpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution, 0.5%DRUGTimolol Maleate Ophthalmic Solution, 0.5% BID
Commercial IOLDEVICECommercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Bimatoprost Implant System (High Dose)DRUGBimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
Bimatoprost Implant System (Low Dose)DRUGBimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOLDEVICECommercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
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Eligibility Criteria
Age Range22 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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: * ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07218783primaryCompletionDate: changed
LOWMay 26, 2026NCT07218796primaryCompletionDate: changed
LOWMay 26, 2026NCT06120842primaryCompletionDate: changed
LOWMay 24, 2026NCT07218796studyFirstPostDate: changed
LOWMay 24, 2026NCT07218783studyFirstPostDate: changed
LOWMay 24, 2026NCT06120842studyFirstPostDate: changed