Active not recruitingPHASE3INTERVENTIONAL

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

This research is designed to learn more about the long-term safety and effectiveness of a treatment called Bimatoprost SR. This is an eye implant used for conditions like open-angle glaucoma or ocular hypertension (high pressure inside the eye). The study is for people who have already completed other trials involving Bimatoprost SR. It aims to see how well the treatment continues to work and if there are any side effects over an extended time. By collecting more information, researchers hope to better understand its benefits and risks for people living with these eye conditions, helping to improve future care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

455

Start

27 Mar 2019

Estimated completion

01 Aug 2026

Open-Angle Glaucoma Ocular Hypertension

What is this study about?

This study is a follow-up for people who have already taken part in earlier research studies about an eye implant called Bimatoprost SR. It's designed for individuals with conditions like open-angle glaucoma or ocular hypertension, which is when you have high pressure inside your eye. These conditions can damage your eyesight if not treated.

The main goal of this particular study is to find out more about how safe and effective Bimatoprost SR is over a longer period. Previous studies would have looked at its short-term effects, but this extension trial allows doctors and researchers to gather important information about its long-term impact on your eyes and overall health. This helps them understand if the benefits continue and if any long-term side effects appear.

By taking part, you would be contributing to a better understanding of this treatment, which could ultimately help many other people with similar eye conditions in the future. The information gathered will be used to make sure treatments are as safe and effective as possible for everyone.

Key takeaways

This study is an extension to existing trials on Bimatoprost SR.
It helps understand the long-term safety and effectiveness of the eye implant.
It's for people already treated with Bimatoprost SR in previous studies.
It aims to manage open-angle glaucoma or ocular hypertension.
Your contribution helps improve future eye treatments.

Who may be eligible?

This study is for adults, aged 18 or older, who have already participated in specific earlier studies about Bimatoprost SR. This includes people who completed one of four Phase 3 studies (known by numbers like 192024-091, -092, -093, or -095) where they received Bimatoprost SR. It also includes those who took part in a Phase 4 study called ARGOS, receiving the DURYSTA version of Bimatoprost SR, and either finished that study or had to leave early without any ongoing safety worries.

There are certain reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, or if you are a woman who could become pregnant and are not using reliable contraception. You also can't be in another clinical trial at the same time, or have any other health issue that would make it difficult for you to complete this study safely.

Additionally, if you were in the earlier Phase 3 studies and received a different eye drop treatment (timolol) in one eye, you wouldn't be eligible for this study for that eye. Also, if you were part of the ARGOS study and had certain eye surgeries for glaucoma in the study eye or the other eye, you might not be able to participate.

Quick self-check

Are you 18 years old or older?
Have you already completed a Bimatoprost SR Phase 3 or ARGOS study?
Are you NOT pregnant, breastfeeding, or planning to be?
Are you NOT currently in another medical research study?
Have you NOT had certain glaucoma surgeries if you were in the ARGOS study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to receive the Bimatoprost SR treatment. The exact details of what taking part involves, such as the number of visits to the clinic, the types of eye checks you'll have, and how long the study will last for you, will be clearly explained by the study team. They will monitor your eye pressure and general eye health to see how the treatment is working and if there are any changes. You'll likely have regular appointments for check-ups and to ensure the treatment is effective and safe for you.

Potential risks and benefits

The potential benefits of continuing with this study include ongoing monitoring of your eye condition and the Bimatoprost SR treatment, which could help manage your glaucoma or high eye pressure. As with any medical treatment, there can be potential risks, such as side effects from the Bimatoprost SR. These will be discussed in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (124)

Trinity Research Group /ID# 240190
Dothan, United States
Arizona Eye Center - West Ray Road /ID# 240239
Chandler, United States
Arizona Glaucoma Specialists /ID# 240212
Phoenix, United States
M&M Eye Institute /ID# 240236
Prescott, United States
Horizon Eye Specialists & Lasik Centers /ID# 240255
Sun City, United States
Angeles Eye Institute /ID# 250397
Culver City, United States
Duplicate_Lakeside Vision Center /ID# 240204
Irvine, United States
Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196
La Jolla, United States
The Eye Research Foundation /ID# 240186
Newport Beach, United States
North Bay Eye Associates Inc. /ID# 248912
Petaluma, United States
Duplicate_Martel Eye Medical Group /ID# 240291
Rancho Cordova, United States
The Clinical Trials Network (CTNx) /ID# 240284
Redding, United States

+112 more sites — see the official record for the full list.

Common questions

What is Bimatoprost SR?

Bimatoprost SR is a small implant placed in the eye to help lower eye pressure, often used for glaucoma or ocular hypertension.

What is glaucoma?

Glaucoma is an eye condition where the optic nerve, which connects your eye to your brain, becomes damaged, often due to high pressure inside your eye.

Why is this study important?

This study is important because it will give doctors long-term information about the safety and effectiveness of Bimatoprost SR, helping future patients.

Can I join if I'm pregnant?

No, women who are pregnant, breastfeeding, or planning a pregnancy cannot join this study.

Do I have to pay to join?

No, a clinical trial will cover the costs of the study-related treatment and visits.