Study Comparing Brimonidine and Timolol Eye Drops 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 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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

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
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
General Hospital Of Larissa Koutlibaneio And Triantafylleio	Larissa	Greece
Iaso Thessalia General Clinic Private Obstetrics S.A.	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Gynltaf Hryzjyrr Om Thcdxih	Trikala	Greece
Oohsgodhczejbxgx Aincnyk	Athens	Greece
Gbjgzrl Hvqwenvv Oe Pmcrup Awqcn Ayqpism	Patras	Greece
Gkpkezu Hdyauzop Oj Kfqlxkpc	Karditsa	Greece
Lanyv Gydibvw Hvuzakcr On Azmgpz	Athens	Greece
Uqlfhairva Gtueakr Hnqppast Apvouuy	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.03.2024

Trial locations

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.

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.

Trial ID:

2023-507285-24-00

Protocol code:

BECRO/PS/ETHRA

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?