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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2031-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bimatoprost Implant System / IOL Combination

Group Type EXPERIMENTAL

Bimatoprost Implant System

Intervention Type DRUG

Bimatoprost Implant System used in combination with the SpyGlass IOL

SpyGlass IOL

Intervention Type DEVICE

SpyGlass Intraocular Lens

Timolol Maleate Ophthalmic Solution 0.5%

Group Type ACTIVE_COMPARATOR

Timolol Maleate Ophthalmic Solution, 0.5%

Intervention Type DRUG

Timolol Maleate Ophthalmic Solution, 0.5% BID

Commercial IOL

Intervention Type DEVICE

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

Intervention Type DRUG

SpyGlass IOL

SpyGlass Intraocular Lens

Intervention Type DEVICE

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

Intervention Type DRUG

Commercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Intervention Type DEVICE

Eligibility Criteria

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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

* Uncontrolled systemic disease
* 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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SpyGlass Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Director, Clinical Affairs

Role: CONTACT

949-284-6904

Facility Contacts

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Clinical Research Coordinator

Role: primary

832-553-7100

Related Links

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https://www.spyglasspharma.com/

SpyGlass Pharma Website

Other Identifiers

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SGP-005

Identifier Type: -

Identifier Source: org_study_id

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