Ippokratio General Hospital Of Thessaloniki
Thessaloniki, Greece
Recruiting
A study comparing the effectiveness of brimonidine tartrate and timolol eye drops versus a standard combination in patients with glaucoma or ocular hypertension
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study aims to compare the effectiveness and safety of a new generic version of eye drops containing brimonidine tartrate and timolol against a known medication called Combigan. The research focuses on managing Glaucoma, a condition that can damage the optic nerve, and Ocular Hypertension, which is characterized by high intraocular pressure, or the fluid pressure inside the eye.
During the study, participants will be assigned to one of two groups to receive either the new generic combination or the comparison medication. Both treatments are administered as eye drops. The process involves monitoring the pressure within the eye over a period of time to see how well each medicine works to lower these levels.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Both men and women of any race who are 18 years of age or older may participate.
- Participants must agree to take part in the study by signing a written consent form, which is a document stating that you understand the study and agree to join.
- You must have a diagnosis of open-angle glaucoma (a condition where the pressure inside the eye rises, potentially damaging the optic nerve) in one or both eyes, or ocular hypertension (when the pressure inside the eye is higher than normal, but there is no immediate damage to the optic nerve).
- Your intraocular pressure, which is the fluid pressure inside your eye, must measure between 22 mm Hg and 34 mm Hg at specific times during the day before starting treatment.
- You must not have used any eye drops or medications to lower your eye pressure for at least 4 weeks before the study begins.
- Your visual acuity, which is the sharpness of your vision when wearing your best possible glasses or contacts, must be at least 20/100.
- Women who cannot become pregnant (such as those who have gone through menopause, had a hysterectomy, or had their ovaries removed) or women of childbearing age who use effective birth control are eligible.
- The study doctor must believe that your eye pressure will stay under control with the treatment without causing damage to the optic nerve (the nerve that sends visual information to the brain) or loss of your visual field (the total area you can see when looking straight ahead).
- You must have controlled arterial blood pressure, which means your blood pressure is within a healthy range as determined by the doctor.
- You must be able to understand what is required during the study and agree to come back for all follow-up visits.
Who cannot join the trial?
36 criteria
- A history of long-term or repeating eye inflammation, such as scleritis (inflammation of the white part of the eye), uveitis (inflammation inside the eye), or herpes keratitis (a viral infection of the cornea), or an eye injury within the last 6 months.
- Any eye infection or eye inflammation within the last 3 months.
- Other serious eye conditions, such as severe dry eye, that would make it unsafe to use beta-blockers (a type of medication that can affect heart rate and blood pressure).
- A history of depression, cerebral insufficiency (reduced blood flow to the brain), coronary insufficiency (reduced blood flow to the heart), Raynaud's phenomenon (poor blood flow to fingers or toes), orthostatic hypotension (a sudden drop in blood pressure when standing up), or thromboangiitis obliterans (inflammation of blood vessels).
- Any systemic disease (a disease affecting the whole body) that is not well controlled.
- Current reactive airway disease, such as bronchial asthma or chronic obstructive pulmonary disease (a condition that makes it hard to breathe due to blocked airways).
- Severe allergic rhinitis (severe seasonal or year-round allergies affecting the nose).
- Heart rhythm problems, such as sinus bradycardia (a very slow heart rate), sick sinus syndrome, or heart blocks (interruptions in the electrical signals of the heart), unless managed by a pacemaker.
- Cardiac failure (the heart cannot pump enough blood) or cardiogenic shock (a life-threatening condition where the heart suddenly cannot pump enough blood).
- Previous use of intraocular corticosteroid implants (medication placed directly inside the eye).
- Use of topical eye steroids or other corticosteroids (anti-inflammatory medicines) in the eye within two weeks before starting.
- Use of systemic corticosteroids (steroid medicines taken by mouth or injection) within one month before starting.
- Use of MAO inhibitors or certain antidepressants or psychotropic drugs (medicines that affect mental state or brain chemicals) within one month before starting.
- Severe loss of central visual field (the area of vision you see directly in front of you).
- Injection of steroids into the eye within the last six months.
- Having had refractive surgery (surgery to change vision), filtering surgery, or laser surgery to reduce intraocular pressure (the pressure inside the eye) within the last 12 months.
- Being pregnant, breast-feeding, or being unable to use highly effective birth control.
- Having narrow-angle glaucoma (a specific type of eye pressure condition where the drainage angle is blocked).
- Currently participating in or having finished another drug or medical device trial within the last 30 days.
- Being unable or unwilling to follow the rules and procedures of the study.
- Having a serious illness that makes the doctor believe you should not join.
- Being unwilling to allow your medical data to be stored and used for the study.
- Being legally unable to make your own decisions or being held in an official institution.
- Using corticosteroids at changing doses in the last 30 days.
- Having corneal abnormalities (problems with the clear front part of the eye) that would prevent accurate intraocular pressure measurement.
- Having significant or worsening retinal disease, such as retinal detachment (when the back part of the eye pulls away) or diabetic retinopathy (eye damage caused by diabetes).
- Having eye surgery within the last 3 months or laser eye surgery within the last month.
- Planning to have any kind of eye surgery during the study.
- Having an extremely narrow eye angle or a specific cup/disk ratio (a measurement of the optic nerve) greater than 0.8.
- A history of severe hepatic impairment (liver problems) or renal impairment (kidney problems).
- Taking oral carbonic anhydrase inhibitors (medicines like acetazolamide used to lower eye pressure).
- Using eye treatments like prostamides, prostaglandins, or pilocarpine.
- Using nonsteroidal anti-inflammatory drugs (NSAIDs) in the eye.
- Any change in regular body medications in the last 30 days that could affect intraocular pressure.
- A known hypersensitivity (allergy) to beta-blockers.
- An allergy or poor reaction to any of the ingredients used in the study's eye drops.
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Athens, GreeceVerified University General Hospital Of Alexandroupoli
Alexandroupoli, Greece
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Investigated drugs
Brimonidine-Timolol
is an eye drop used to lower the pressure inside the eye in people with glaucoma or high eye pressure.
Combigan
is an eye drop used to lower the pressure inside the eye in people with glaucoma or high eye pressure.
What is already known about the treatment
Brimonidine-Timolol
This medication is administered as eye drops applied directly into the eye to treat high pressure inside the eye, known as ocular hypertension or glaucoma. It is a combination of two different types of drugs that work together to lower eye pressure by decreasing the production of fluid in the eye and increasing its natural drainage. This specific formulation is currently being studied as a generic version of existing treatments to ensure it works just as well as branded options.
Combigan
This is an established eye drop solution used to manage conditions like glaucoma and high eye pressure. It contains two active ingredients that work at a molecular level to reduce the amount of fluid produced in the eye and improve its outflow, thereby lowering internal pressure. As a well-known medical product, it serves as the standard against which new generic versions are compared in this study.
Investigated diseases
Ocular Hypertension
This condition is characterized by an increase in the pressure inside the eye. It occurs when the fluid within the eye does not drain properly. The condition can exist without any visible damage to the optic nerve. Over time, the elevated pressure may continue to rise.
Glaucoma
This is a group of eye conditions that damage the optic nerve, which is essential for good vision. It is often associated with abnormally high pressure inside the eye. As the disease progresses, the pressure can cause gradual damage to the nerve fibers. This damage typically leads to a slow loss of vision.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523227-22-00Protocol codeBECRO/OV/BRIMOTIMEstimated enrolment180 patientsSponsorOmniVision GmbH
sourced from the EU Clinical Trials Register and site verification
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