Not recruiting

Study Comparing Brimonidine and Timolol Eye Drops for Patients with Open-Angle Glaucoma or Ocular Hypertension

Verified siteRegistered drugNo 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 two eye conditions: open-angle glaucoma and ocular hypertension. Open-angle glaucoma is a condition where increased pressure inside the eye can lead to changes in the optic nerve and vision loss. Ocular hypertension refers to higher-than-normal pressure in the eye, which can also lead to glaucoma if not managed. The study will compare two treatments: a new generic formulation of eye drops containing brimonidine and timolol, and a marketed eye drop solution known as Combigan. Both treatments are designed to help lower the pressure inside the eye.

The purpose of the study is to determine if the new generic eye drops are as effective and well-tolerated as Combigan in patients with open-angle glaucoma or ocular hypertension. Participants in the study will use one of the two eye drop solutions over a period of 12 weeks. The study will monitor changes in eye pressure at different times of the day to assess the effectiveness of the treatments.

Throughout the study, participants will have regular check-ups to measure the pressure in their eyes and ensure the treatment is working as intended. The study aims to provide valuable information on whether the new generic eye drops can be a suitable alternative to Combigan for managing eye pressure in patients with these conditions.

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
Joining the study
Upon joining the study, the patient is required to provide written consent and agree to the study's terms.
The patient must meet specific criteria, such as being at least 18 years old and having a diagnosis of open angle glaucoma or ocular hypertension.
Step 2
Baseline assessment
The patient's eye pressure, known as intraocular pressure (IOP), is measured at 08:00, 12:00, and 16:00 hours.
The patient must have an average IOP of at least 22 mmHg and no more than 35 mmHg in at least one eye.
Step 3
Medication administration
The patient receives either the test product, a generic formulation of brimonidine 0.2% and timolol 0.5% eye drops, or the reference product, Combigan® eye drops.
The eye drops are administered for a duration of 12 weeks.
Step 4
Follow-up visits
The patient attends follow-up visits to monitor IOP changes at weeks 2, 6, and 12.
During these visits, IOP is measured at 08:00, 12:00, and 16:00 hours to assess the effectiveness of the treatment.
Step 5
End of treatment assessment
At the end of the 12-week treatment period, the patient's IOP is measured again at 08:00 to compare with baseline measurements.
The primary goal is to determine if the test product is as effective as the reference product in reducing IOP.

Who can join the trial?

11 criteria

Must be a male or female, of any race, and at least 18 years old.
Must understand the requirements of the clinical trial and agree to return for follow-up visits.
Must be willing to provide written consent and agree to data protection before any trial procedures.
Must have been diagnosed with either one or both eyes having open angle glaucoma or ocular hypertension (high pressure in the eye).
Must have an average eye pressure (IOP) between 22 and 35 mmHg, measured at specific times of the day before treatment starts.
Must not have used any eye pressure-lowering drugs for at least 4 weeks before the study.
Must have a best-corrected visual acuity of at least 20 out of 100, which means the ability to see clearly with glasses or contact lenses.
Must not have started any new medications that could affect eye pressure in the last 30 days, or must continue current medications without changes for 30 days before and during the study.
Must have controlled blood pressure according to the investigator's opinion.
If female, must either be unable to become pregnant (due to menopause, surgery, or other reasons) or, if of reproductive age and sexually active, must use effective birth control methods during the study.
The investigator must expect that the new treatment will control eye pressure without causing damage to the optic nerve or worsening vision.

Who cannot join the trial?

8 criteria

Patients who have any other eye diseases besides open angle glaucoma or ocular hypertension.
Individuals who have had eye surgery in the past three months.
People who are allergic to the study medications or any of their ingredients.
Patients who are currently using other medications that might interfere with the study treatment.
Women who are pregnant or breastfeeding.
Individuals with severe health conditions that might affect the study results.
Patients who have participated in another clinical trial within the last 30 days.
People who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Ippokratio General Hospital Of Thessaloniki
Verified
Thessaloniki, Greece
Laiko General Hospital Of Athens
Verified
Athens, Greece
University General Hospital Attikon
Verified
Athens, Greece

Trial locations

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Investigated drugs

Brimonidine/Timolol Eye Drops
are a new generic formulation used in this clinical trial. These eye drops are designed to help reduce high pressure inside the eye, which is important for patients with open-angle glaucoma or ocular hypertension. The combination of brimonidine and timolol works by decreasing the amount of fluid within the eye, thereby lowering the pressure.
Combigan® Eye Drops
are the marketed version of the eye drops being compared in this trial. Like the generic formulation, Combigan® is used to lower high eye pressure in patients with open-angle glaucoma or ocular hypertension. It contains the same active ingredients, brimonidine and timolol, and works in a similar way to reduce fluid production in the eye and decrease pressure.

What is already known about the treatment

Brimonidine/Timolol Eye Drops – This medication is administered as eye drops and is used to treat open-angle glaucoma and ocular hypertension. It is currently being studied in clinical trials to compare its efficacy and tolerability against a marketed product. The main therapeutic indication is to reduce intraocular pressure, which helps prevent damage to the optic nerve and loss of vision. At the molecular level, Brimonidine works by decreasing the production of aqueous humor and increasing its outflow, while Timolol reduces aqueous humor production. This combination belongs to the pharmacological class of ophthalmic glaucoma agents.

Investigated diseases

Open Angle Glaucoma – Open angle glaucoma is a condition where the drainage angle for eye fluid remains open, but the trabecular meshwork is partially blocked, leading to increased intraocular pressure. This pressure can cause damage to the optic nerve, resulting in gradual vision loss. Initially, there may be no symptoms, but as the disease progresses, peripheral vision may decrease. Over time, this can lead to tunnel vision and, if untreated, can result in blindness. The progression is typically slow, and many people may not notice vision changes until significant damage has occurred. Regular eye exams are crucial for early detection and management.