Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2027-11-30

Brief Summary

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This trial is a randomized study to evaluate and compare two doses of 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.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bimatoprost Implant System (High Dose) / IOL Combination

Group Type EXPERIMENTAL

Bimatoprost Implant System (High Dose)

Intervention Type DRUG

Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL

SpyGlass IOL

Intervention Type DEVICE

SpyGlass Intraocular Lens

Bimatoprost Implant System (Low Dose) / IOL Combination

Group Type EXPERIMENTAL

Bimatoprost Implant System (Low Dose)

Intervention Type DRUG

Bimatoprost Implant System (Low Dose) 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

Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Intervention Type DEVICE

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Interventions

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Bimatoprost Implant System (High Dose)

Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL

Intervention Type DRUG

Bimatoprost Implant System (Low Dose)

Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL

Intervention Type DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution 0.5% BID

Intervention Type DRUG

Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Intervention Type DEVICE

SpyGlass IOL

SpyGlass 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, pseudoexfoliation, 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