Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-reference, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Combination of Brinzolamide 10mg/ml + Timolol 5mg/ml Eye Drops versus Azarga® 10mg/ml + 5mg/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 used to treat eye conditions like glaucoma or high pressure inside the eye (called ocular hypertension). One eye drop is already widely used, named Azarga. The other is a new, generic version of a similar combination of medicines. The main goal of the study is to see if this new generic eye drop works just as well as Azarga in lowering eye pressure. Researchers will also be checking how safe each eye drop is and if they cause any unwanted side effects. The study involves adults aged 18 and over who have been diagnosed with either open-angle glaucoma or high eye pressure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

OmniVision GmbH

Enrolment target

234

Start

20 May 2024

Ocular Hypertension Glaucoma

What is this study about?

This study is a clinical trial designed to compare two different eye drop treatments. It's for people who have either open-angle glaucoma or a condition called ocular hypertension, which means they have high pressure inside their eyes.

The main purpose is to see if a newer, generic combination eye drop (called Brinzolamide-Timolol) works just as well as an existing, well-known eye drop called Azarga. Both eye drops contain the same two active medicines in the same strengths. The study will carefully measure how much each eye drop lowers the pressure in the eye. They'll also be looking closely at any side effects to understand how well people tolerate each treatment.

This type of study, known as a 'Phase III' trial, is a crucial step before a new generic medicine can become widely available. By comparing it directly with an established treatment, researchers can build confidence that the generic option is a safe and effective alternative for patients.

Key takeaways

This study compares two eye drop treatments for high eye pressure and glaucoma.
It checks if a new generic eye drop works as well as the standard Azarga drops.
Scientists will measure eye pressure and look for any side effects.
Participation involves using eye drops and attending check-ups for about 12 weeks.
The study helps determine if a safe and effective generic treatment can be offered.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so older adults can also take part.

Participants must have been diagnosed by a doctor with either open-angle glaucoma or ocular hypertension, which is a condition where the pressure inside your eye is too high.

Both men and women are welcome to participate in this study. The researchers will have a full list of things they look for in a participant, so your doctor can help determine if you meet all the specific requirements.

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 male or female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you’ll be given one of the two eye drop treatments – either the new generic one or Azarga. You won't know which one you're receiving, nor will the doctors examining your eyes, to ensure fair results. You'll use these eye drops regularly as instructed. Over a period of 12 weeks, you will have several visits to the study clinic. During these visits, the research team will measure your eye pressure multiple times throughout the day and ask about any side effects you might be experiencing. The total duration of your participation in the study will be at least 12 weeks, including the initial assessment.

Potential risks and benefits

Taking part in this study could offer you a new treatment option for your eye condition. If the generic eye drop proves to be effective, it could lead to more affordable choices for managing glaucoma or high eye pressure in the future. However, as with any medication, there's always a chance of side effects, which the study will carefully monitor. You have the full right to 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 open-angle glaucoma?

It's an eye condition where the nerve connecting your eye to your brain is damaged, usually because of high pressure inside your eye. This can slowly lead to sight loss.

What is ocular hypertension?

This means the pressure inside your eye is higher than normal. It doesn't always cause vision loss, but it can increase your risk of developing glaucoma.

What does 'non-inferiority' mean in a study?

It means the study aims to show that the new generic eye drop is not worse than the existing Azarga eye drop, and works just as well to lower eye pressure.

Will I know which eye drops I'm getting?

No, neither you nor the doctors examining you will know if you're getting the new generic eye drops or Azarga. This is called 'blinding' and helps keep the study fair.

How long will I be in the study?

Your involvement in the study will last for at least 12 weeks, during which you'll have regular check-ups.