Completed

Sustained Release Bimatoprost Implant for Ocular Hypertension and Open-Angle Glaucoma

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Study Aim

This study aims to evaluate the effectiveness and safety of a sustained release bimatoprost implant in adults with ocular hypertension and open-angle glaucoma.

What is being tested

Bimatoprost Implant System / IOL Combination

Combination Product
Who is being recruted

Cataract+2

+ Eye Diseases

+ Glaucoma

Over 22 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorSpyGlass Pharma, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 21, 2022

Actual date on which the first participant was enrolled.

This study aims to evaluate the safety and effectiveness of a new implant system for individuals with ocular hypertension or mild to moderate open-angle glaucoma. Ocular hypertension and open-angle glaucoma are conditions that can lead to increased pressure inside the eye, potentially damaging the optic nerve and affecting vision. The study investigates the use of the SpyGlass Bimatoprost Implant System combined with an intraocular lens (IOL) in patients undergoing cataract surgery. It explores how different doses of the implant might help in managing eye pressure, offering potential new solutions for these common eye conditions. Participants in this study undergo cataract surgery followed by the implantation of the SpyGlass Bimatoprost Implant System. This implant is provided in three different dose levels: low, medium, and high. The study spans six months, during which participants attend several follow-up visits to monitor their eye health and measure intraocular pressure (IOP). The IOP is assessed using a unique method involving two observers to ensure accuracy. While the study does not involve blinding, meaning participants and doctors know the treatment being given, the careful measurement technique ensures precise evaluation of the implant's effectiveness in controlling eye pressure.

Official TitleA Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma
NCT07154797
Principal SponsorSpyGlass Pharma, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CataractEye DiseasesGlaucomaLens DiseasesOcular Hypertension

Criteria

3 inclusion criteria required to participate
Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension

Planned removal of cataract

Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension

4 exclusion criteria prevent from participating
Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening

History of incisional/refractive corneal surgery

Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders

Other ocular diseases, pathology, or conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass Intraocular Lens

Group II

Experimental
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass Intraocular Lens

Group III

Experimental
Bimatoprost Implant System (Medium Dose) used in combination with the SpyGlass Intraocular Lens

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Centro Oftalmológico Robles

Santa Rosa de Copán, HondurasOpen Centro Oftalmológico Robles in Google Maps
CompletedOne Study Center