AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-comparator, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Dose Combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml Eye Drops versus Combigan® 2 mg/ml + 5 mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension

This research is looking at two types of eye drops designed to help people with glaucoma or high pressure in their eyes (ocular hypertension). One eye drop is a new, generic version called Brimonidine-Timolol, and the other is a well-known brand called Combigan. Both drops contain the same active ingredients in the same strengths. The main goal of the study is to find out if the new generic eye drop is just as effective as Combigan at lowering the pressure inside the eye over a 12-week period. They will also be checking if both eye drops cause similar side effects. This is a "Phase III" study, which means it's a major step before a new medicine can be widely used by the public. Participants will be given one of the two eye drops, and everyone involved will be carefully monitored.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

OmniVision GmbH

Enrolment target

180

Start

27 Mar 2026

Ocular Hypertension, Glaucoma

What is this study about?

This clinical trial is designed to compare two different eye drop treatments for specific eye conditions: glaucoma and ocular hypertension (high pressure inside the eye). Both of these conditions can, if left untreated, lead to vision loss. The treatments being compared are Brimonidine-Timolol eye drops and Combigan eye drops. Both contain the same combination of two active medicines, Brimonidine Tartrate and Timolol, at the same strength.

The aim of the study is to see if the new Brimonidine-Timolol eye drops work just as well as the established Combigan brand. This type of study is called a "non-inferiority" trial, which means the researchers want to prove that the new generic version is not worse than the existing treatment, rather than trying to prove it's better. They'll be focusing on how much the eye drops can lower the pressure inside your eye over a 12-week period. They will also keep a close eye on any side effects to make sure both treatments are equally safe.

Understanding if a new generic medicine works just as well and is as safe as a brand-name medicine is really important. If proven effective, generic medicines can offer a more affordable option for patients and the NHS, making essential treatments more accessible.

Key takeaways

Compares a new generic eye drop to a standard brand for eye pressure.
Aims to see if the generic works just as well and is as safe.
For adults with glaucoma or high eye pressure (ocular hypertension).
Involves using eye drops daily and attending regular clinic visits for 12 weeks.
You won't know which eye drop you receive, ensuring fair results.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have been diagnosed with either open-angle glaucoma or ocular hypertension. These are specific conditions where the pressure inside your eye is too high. Your doctor will need to confirm this diagnosis.

There will also be other specific medical criteria that your doctor will check to ensure the study is safe and appropriate for you. For example, you might not be able to join if you have certain other health conditions or are taking particular medications.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with open-angle glaucoma?
Have you been diagnosed with ocular hypertension (high eye pressure)?
Are you able to attend clinic visits regularly for about 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive one of two types of eye drops: either the Brimonidine-Timolol eye drops or the Combigan eye drops. Neither you nor the doctors assessing you will know which treatment you are receiving, which helps ensure the results are unbiased.

Your participation will involve several visits to the clinic over a period of 12 weeks (about three months). At these visits, doctors will measure the pressure inside your eye multiple times throughout the day, both at the beginning of the study and at specific points during the treatment period, such as at 2 weeks, 6 weeks, and 12 weeks. They will also carefully record any side effects you experience.

The total duration of your active involvement in the study will be approximately 12 weeks, with follow-up appointments to track your progress and assess the success of the treatment.

Potential risks and benefits

Potential benefits of taking part could include receiving regular and expert monitoring of your eye condition and access to a medication that could lower your eye pressure, which is crucial for managing glaucoma or ocular hypertension. You would also be contributing to medical knowledge that could help future patients. Potential risks might include experiencing side effects from the eye drops, such as eye irritation, redness, or other more general effects. It's important to remember that you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is glaucoma?

Glaucoma is an eye condition where the nerve connecting your eye to your brain is damaged, usually due to high pressure inside your eye. This can lead to vision loss if not treated.

What is ocular hypertension?

Ocular hypertension means the pressure inside your eye is higher than normal, but you don't necessarily have optic nerve damage or vision loss yet. It's a risk factor for developing glaucoma.

What does 'generic' mean?

A generic medicine contains the same active ingredients as a brand-name medicine and works in the same way, but is usually less expensive once the original patent has expired.

Will I know which eye drops I am getting?

No, this is an 'observer-blind' study, meaning neither you nor the doctors assessing your eyes will know if you are receiving the generic Brimonidine-Timolol or the brand-name Combigan. This helps make the study fair.

How long will I need to use the study eye drops?

You will be using the study eye drops and attending appointments for approximately 12 weeks (about three months).