Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
NCT ID: NCT07218783
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-10-15
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bimatoprost Implant System / IOL Combination
Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass IOL
SpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution 0.5%
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID
Commercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Interventions
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Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass IOL
SpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID
Commercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Eligibility Criteria
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Inclusion Criteria
* 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
* History of incisional/refractive corneal surgery
* Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma
* History of incisional glaucoma surgery or intraocular injections
* Other ocular diseases, pathology, or conditions
22 Years
ALL
No
Sponsors
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SpyGlass Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Yoo, OD
Role: STUDY_CHAIR
SpyGlass Pharma
Locations
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Houston Eye Associates
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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SpyGlass Pharma Website
Other Identifiers
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SGP-005
Identifier Type: -
Identifier Source: org_study_id
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