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Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)

NCT07218783 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-10-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bimatoprost Implant System

Bimatoprost Implant System used in combination with the SpyGlass IOL

DEVICE

SpyGlass IOL

SpyGlass Intraocular Lens

DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

DEVICE

Commercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Sponsors & Collaborators

  • SpyGlass Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Yoo, OD · SpyGlass Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2029-03-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218783 on ClinicalTrials.gov