Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called Bimatoprost SR for patients with Open-angle Glaucoma or Ocular Hypertension. These are eye conditions that can lead to increased pressure inside the eye, potentially causing damage to the optic nerve and affecting vision. The treatment being tested is an implant that releases the medication Bimatoprost over time to help lower the pressure in the eye.

The purpose of the study is to evaluate how safe Bimatoprost SR is for patients and how long it can effectively reduce eye pressure. Participants in the study will receive the implant and be monitored over a period to assess the treatment’s impact on their eye health. The study will involve regular check-ups to observe any changes in vision and eye pressure, as well as to ensure the treatment is working as intended.

Throughout the study, participants will be observed for any side effects or changes in their eye condition. The study aims to provide valuable information on the long-term use of Bimatoprost SR for managing Open-angle Glaucoma and Ocular Hypertension, helping to determine its potential as a reliable treatment option for these conditions.

1 joining the study

Upon joining the study, the patient must have completed one of the previous Bimatoprost SR Phase 3 studies or the open-label Phase 4 ARGOS study without ongoing safety concerns.

The patient must provide written informed consent and authorization for the use and release of personal health information.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s current eye condition. This includes checking visual field, visual acuity, and other eye health parameters.

The assessment will also involve a review of any previous treatments received during the lead-in study.

3 bimatoprost sr administration

The patient will receive Bimatoprost SR, which is an implant administered through intracameral use (injection into the eye).

The purpose of this treatment is to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

4 follow-up visits

Regular follow-up visits will be scheduled to monitor the patient’s response to the treatment and to assess the safety and efficacy of Bimatoprost SR.

During these visits, various eye assessments will be conducted, including visual field tests, visual acuity checks, and other eye health evaluations.

5 prn retreatment

If necessary, the patient may receive additional Bimatoprost SR treatments on a PRN (as needed) basis, depending on the patient’s response and the investigator’s discretion.

The timing of these treatments will be determined based on the patient’s individual needs and the study’s guidelines.

6 end of study

The study is estimated to conclude by April 19, 2025.

At the end of the study, a final assessment will be conducted to evaluate the long-term safety and efficacy of Bimatoprost SR in the patient.

Who Can Join the Study?

Patients must provide written informed consent, which means they agree to participate in the study and allow the use of their health information. This must be done according to local privacy laws. Patients must not be in prison and should be able to give consent freely.
Patients should be able to understand and follow the study instructions and be likely to attend all required visits and procedures.
Females who can have children must have a negative pregnancy test at the start of the study.
Patients must have completed one of the previous Bimatoprost SR Phase 3 studies and meet specific conditions regarding their treatment, such as not needing additional medication or having certain follow-up requirements.
Patients who completed or left early from the open-label Phase 4 ARGOS study without ongoing safety concerns and meet specific conditions regarding their treatment.

Who Cannot Join the Study?

Patients who have any other eye conditions that could affect the study results.
Patients who have had eye surgery in the past three months.
Patients who are using other medications that might interfere with the study treatment.
Patients who have allergies to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients with serious health conditions that could affect their safety during the study.
Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Pole Vision Val D’Ouest	Ecully	France
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)	Duesseldorf	Germany
Pellegrin Hospital	Bordeaux	France
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Oftalmika Sp. z o.o.	Bydgoszcz	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.11.2019
Germany	Not recruiting	14.11.2019
Poland	Not recruiting	14.11.2019
Spain	Not recruiting	14.11.2019

Trial locations

Investigated drugs:

Bimatoprost

Bimatoprost SR is a medication used in this clinical trial to treat patients with open-angle glaucoma or ocular hypertension. It is designed to help lower the pressure inside the eye, which can prevent damage to the optic nerve and loss of vision. The trial aims to assess the long-term safety and effectiveness of this medication in maintaining lower eye pressure over time.

Investigated diseases:

Ocular hypertension

Ocular Hypertension – Ocular hypertension is a condition characterized by higher than normal pressure inside the eye, known as intraocular pressure (IOP). Unlike glaucoma, it does not cause any noticeable damage to the optic nerve or loss of vision. However, it is considered a risk factor for developing glaucoma. The condition progresses without symptoms, making regular eye exams crucial for detection. Monitoring and managing IOP can help prevent potential progression to glaucoma.

Open-angle Glaucoma – Open-angle glaucoma is a chronic eye condition where the drainage angle formed by the cornea and iris remains open, but the trabecular meshwork is partially blocked. This blockage leads to a gradual increase in intraocular pressure, which can damage the optic nerve. The disease progresses slowly and often without noticeable symptoms until significant vision loss occurs. It is the most common form of glaucoma and can affect peripheral vision first, eventually leading to tunnel vision if untreated. Regular eye examinations are essential for early detection and management.

Trial ID:

2023-504601-36-00

Protocol code:

1698-302-007

NCT ID:

NCT03891446

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension

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