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Study on the Effects of Bimatoprost SR and Timolol in Patients with Open-angle Glaucoma or Ocular Hypertension

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a treatment for two eye conditions: open-angle glaucoma and ocular hypertension. These conditions can lead to increased pressure inside the eye, which may damage the optic nerve and affect vision. The treatment being tested is called Bimatoprost SR, which is an implant designed to help lower the pressure in the eye. The study will also involve the use of Timolol, an eye drop solution that is commonly used to treat high eye pressure.

The purpose of the study is to evaluate how well Bimatoprost SR can lower eye pressure and how safe it is for patients with open-angle glaucoma or ocular hypertension. Participants in the study will receive either Bimatoprost SR or a placebo, and some may also use Timolol eye drops. The study will involve initial and repeated administrations of the treatment over a period of time to monitor its effects on eye pressure.

Throughout the study, participants will have regular check-ups to measure the pressure in their eyes and to ensure their safety. The study aims to provide valuable information on the potential benefits of Bimatoprost SR for people with these eye conditions. The results could help improve treatment options for managing eye pressure and preventing vision loss in patients with open-angle glaucoma or ocular hypertension.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial administration
Receive the first dose of Bimatoprost SR implant. This medication is administered through intracameral use, which means it is placed inside the eye.
The purpose of this step is to begin lowering the pressure inside the eye, known as intraocular pressure (IOP), which is important for managing conditions like open-angle glaucoma or ocular hypertension.
Step 2
Follow-up visits
Attend scheduled follow-up visits to monitor the effectiveness of the treatment. During these visits, the change in IOP from the baseline will be evaluated at specific times.
These visits are crucial for assessing how well the treatment is working and ensuring the safety of the patient.
Step 3
Repeated administration
Receive additional doses of Bimatoprost SR as needed, based on the results of the follow-up visits. The goal is to maintain the desired IOP levels.
The frequency and number of these administrations will depend on the individual response to the treatment.
Step 4
Timolol eye drops
Use Timolol eye drops as prescribed. This medication is applied directly to the eye and helps further reduce IOP.
The dosage and frequency will be determined by the healthcare provider, based on the patient's specific needs.
Step 5
Final assessment
Undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.
This assessment will include measuring the IOP and checking for any side effects or complications from the treatment.

Who can join the trial?

8 criteria

The patient must have a diagnosis of either **open-angle glaucoma** (a type of eye condition) or **ocular hypertension** (higher than normal pressure in the eye) in each eye, and both eyes need treatment to lower eye pressure.
The doctor believes that either eye can be treated effectively with eye drops that are **beta-blockers** (like timolol) as the only treatment.
The doctor believes that either eye can be treated effectively with eye drops that are **prostamides**, **prostaglandins**, or **prostaglandin analogs** (like LUMIGAN, Xalatan, Travatan) as the only treatment.
The angle between the iris and cornea in the study eye must be confirmed as suitable by two eye doctors using specific criteria: a **Shaffer Grade** of 3 or more and a **Van Herick examination** showing a depth of at least half the corneal thickness.
At the first visit, the eye being studied must have an **intraocular pressure (IOP)** (pressure inside the eye) between 22 and 32 mm Hg, and the other eye must have an IOP of 32 mm Hg or less.
At the first visit, two hours later, the eye being studied must have an IOP between 19 and 32 mm Hg, and the other eye must have an IOP of 32 mm Hg or less.
By the first visit, the final count of **endothelial cells** (cells lining the inside of the cornea) in both eyes must be confirmed as suitable by a Reading Center, with at least one eye qualified for the study.
Both men and women can participate in the study.

Who cannot join the trial?

8 criteria

Patients who have any other eye diseases besides ocular hypertension or open-angle glaucoma cannot participate. Ocular hypertension means higher pressure inside the eye, and open-angle glaucoma is a condition where the eye's drainage system is open but not working properly, leading to increased eye pressure.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults only.
Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
Patients who have any medical conditions that might interfere with the study or its results cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had recent eye surgery or plan to have eye surgery during the study cannot participate.
Patients who are allergic to the study medication or its ingredients cannot participate.
Patients who are pregnant or breastfeeding cannot participate.

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Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany

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Investigated drugs

Bimatoprost SR is a medication used in this clinical trial to help lower the pressure inside the eye, known as intraocular pressure (IOP). This is important for patients with open-angle glaucoma or ocular hypertension, as high eye pressure can lead to vision problems or even blindness if not managed properly. The trial is testing the effectiveness and safety of Bimatoprost SR when given to patients, to see how well it works in reducing eye pressure and to ensure it is safe for use.

What is already known about the treatment

Bimatoprost SR – This medication is administered as an implant directly into the eye. It is currently being studied in clinical trials to assess its effectiveness and safety for treating open-angle glaucoma and ocular hypertension. Bimatoprost SR works by lowering intraocular pressure, which is crucial in managing these eye conditions. It belongs to the class of medications known as prostaglandin analogs, which help increase the outflow of fluid from the eye, thereby reducing pressure.

Investigated diseases

Ocular Hypertension
Ocular hypertension occurs when the pressure inside the eye, known as intraocular pressure, is higher than normal. This condition does not cause any noticeable symptoms, and vision remains unaffected initially. However, if left unchecked, it can lead to damage to the optic nerve, potentially resulting in glaucoma. Regular eye examinations are crucial to monitor and manage this condition effectively. It is important to differentiate ocular hypertension from glaucoma, as the latter involves optic nerve damage and vision loss.
Open-Angle Glaucoma
Open-angle glaucoma is a chronic eye condition characterized by a gradual increase in intraocular pressure, leading to damage to the optic nerve. This type of glaucoma is the most common form and progresses slowly, often without noticeable symptoms in the early stages. As the disease advances, peripheral vision is typically affected first, and if untreated, it can lead to significant vision loss. The "open-angle" refers to the angle between the iris and cornea, which remains open, but the drainage canals become less efficient over time. Regular eye check-ups are essential for early detection and management.