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Study on Glaucoma Treatment: Comparing Brimonidine, Pilocarpine Nitrate, and Brinzolamide in Patients with Newly Diagnosed Open-Angle Glaucoma

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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 progression of glaucoma, specifically open-angle glaucoma and PEX glaucoma. Glaucoma is a condition that affects the eyes and can lead to vision loss due to damage to the optic nerve. The study aims to compare two different treatment approaches for patients who have been newly diagnosed with this condition. The treatments being tested include a single medication approach and a combination of medications, which may include additional treatments like laser therapy. The medications involved in this study are brimonidine, pilocarpine nitrate, brinzolamide, timolol maleate, latanoprost, betaxolol, bimatoprost, dorzolamide hydrochloride, travoprost, and tafluprost. Some of these medications may be used in combination to enhance their effectiveness.

The purpose of the study is to observe and compare how quickly the disease progresses in patients receiving different types of treatment. Participants will be randomly assigned to either the intensive treatment group or the conventional treatment group. The study will monitor the rate of vision loss and any changes in the condition over time. This will help determine which treatment approach is more effective in slowing down the progression of glaucoma. The study will also consider the quality of life of the participants and how well they adhere to the treatment plan.

Participants in the study will receive treatment for a period of up to 120 days, with regular follow-ups to assess their condition. The study will continue to collect data on the participants' eye health and vision changes. This information will be used to better understand the effectiveness of the treatments and to improve future care for individuals with glaucoma. The study is expected to conclude by the end of 2027.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a diagnosis of open-angle glaucoma or PEX glaucoma in one or both eyes, with a Visual Field Index (VFI) of 65% or higher.
The patient must be between 40 and 78 years old and should not have been previously treated with medication to lower eye pressure.
Step 2
Randomization
Participants are randomly assigned to one of two treatment groups: intensive non-invasive treatment or conventional stepwise treatment.
Step 3
Treatment initiation
For the intensive treatment group, a combination of eye drops is used, which may include medications such as brimonidine, pilocarpine nitrate, brinzolamide, timolol maleate, latanoprost, travoprost, betaxolol, bimatoprost, dorzolamide hydrochloride, and tafluprost. These are administered through ocular use.
The conventional treatment group starts with a single eye drop therapy and may progress to additional medications as needed.
Step 4
Follow-up and monitoring
Regular follow-up visits are scheduled to monitor the progression of the disease and the effectiveness of the treatment. The primary focus is on the rate of progression of vision loss.
Secondary aspects such as quality of life and compliance with the treatment regimen are also evaluated.
Step 5
Study duration
The study is expected to continue until December 31, 2027, allowing for long-term observation of treatment effects.

Who can join the trial?

4 criteria

The patient must have been newly diagnosed with **open-angle glaucoma** or **PEX glaucoma** in one or both eyes. Open-angle glaucoma is a common type of glaucoma where the eye's drainage canals become clogged over time, leading to increased eye pressure. PEX glaucoma is a type of glaucoma associated with a condition called pseudoexfoliation syndrome.
The **Visual Field Index (VFI)** should be 65% or higher. The VFI is a measure of how much vision is left, with 100% being full vision.
The patient should not have been previously treated with medications that lower **intraocular pressure**. Intraocular pressure is the fluid pressure inside the eye.
The patient should be between the ages of 40 and 78 at the time of joining the study.

Who cannot join the trial?

4 criteria

Patients who do not have a confirmed diagnosis of open-angle glaucoma or PEX glaucoma cannot participate.
Patients who have not experienced vision loss with damage to the optic nerve fibers are excluded.
Patients who are not within the specified age range for the study are excluded.
Patients who are part of a vulnerable population, meaning they may need special protection or care, are not eligible.

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Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Mono Drop Therapy
is a treatment approach where a single type of eye drop is used to manage glaucoma. This therapy aims to reduce eye pressure and slow down the progression of the disease by using one medication at a time.
Combo Drop Therapy
involves using a combination of different eye drops to treat glaucoma. This method is designed to enhance the effectiveness of treatment by targeting the condition with multiple medications simultaneously, which may help in better controlling eye pressure.
Third Medication
refers to an additional drug used alongside the combo drop therapy. This medication is included to further assist in managing glaucoma by providing an extra layer of treatment to help prevent vision loss.
LTP 360°
stands for Laser Trabeculoplasty, a non-invasive laser treatment that targets the drainage angle of the eye. This procedure helps to improve fluid outflow, thereby reducing eye pressure and slowing the progression of glaucoma.

What is already known about the treatment

Mono Drop Therapy
This medication is administered in the form of eye drops, applied directly to the eye. It is currently being studied in clinical trials for its effectiveness in treating open-angle glaucoma, a condition characterized by increased pressure in the eye that can lead to vision loss. The main therapeutic indication is to reduce intraocular pressure to prevent further damage to the optic nerve. At the molecular level, it works by decreasing the production of fluid within the eye or increasing its outflow, thereby lowering eye pressure. It is classified pharmacologically as an ocular hypotensive agent.
Combo Drop Therapy + Third Medication + LTP 360°
This treatment involves a combination of eye drops and a laser procedure, applied directly to the eye. It is under investigation in clinical trials for its potential to treat open-angle glaucoma more effectively than conventional methods. The primary therapeutic goal is to significantly reduce intraocular pressure and slow disease progression. The mechanism of action includes a synergistic effect where the medications enhance fluid outflow and the laser treatment further facilitates drainage. This approach is classified as a combination therapy for glaucoma management.

Investigated diseases

Open-Angle Glaucoma
This is a chronic eye condition where the drainage canals in the eyes become clogged over time, leading to increased eye pressure. This pressure can damage the optic nerve, which is crucial for vision. The disease progresses slowly and often without noticeable symptoms until significant vision loss occurs. It primarily affects peripheral vision initially, and if untreated, it can lead to tunnel vision. Regular eye exams are important for early detection, as the condition can be managed to slow progression.
PEX Glaucoma
Pseudoexfoliation (PEX) glaucoma is a form of secondary open-angle glaucoma characterized by the accumulation of fibrous material in the eye. This material can block the drainage system, leading to increased intraocular pressure. The disease can progress more rapidly than primary open-angle glaucoma and may cause optic nerve damage. It often affects one eye more than the other and can lead to significant vision impairment if not monitored. Early detection and management are crucial to control the pressure and prevent vision loss.