MedTrace Logo

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

NCT06120842 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-08-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bimatoprost Implant System (High Dose)

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

DRUG

Bimatoprost Implant System (Low Dose)

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

DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution 0.5% BID

DEVICE

Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

DEVICE

SpyGlass IOL

SpyGlass Intraocular Lens

Sponsors & Collaborators

  • SpyGlass Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Hafner · SpyGlass Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2025-01-31
Completion
2027-11-30
FDA Drug
Yes
FDA Device
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 NCT06120842 on ClinicalTrials.gov