Non-inferiority Clinical Trial for Comparing the Efficacy and Tolerability of a new fixed-Combination Generic Formulation of Brimonidine 0.2%/Timolol 0.5% eye drops, solution in single-dose containers vs Combigan® eye drops, solution in Patients with Open Angle Glaucoma or Ocular Hypertension
This clinical trial is designed to see if a new generic eye drop, which contains the same two medicines as an existing one (Combigan®), works just as well and is tolerated as well by people with a condition called open-angle glaucoma or high eye pressure (ocular hypertension). These conditions can damage the nerve at the back of the eye and, if not treated, can lead to vision problems. The study focuses on measuring changes in eye pressure at different times of the day over 12 weeks to ensure the new eye drop is effective. It's a 'Phase III' study, meaning it's a final check before the new generic medicine could potentially become widely available, offering a more affordable treatment option.
At a glance
What is this study about?
This study is looking at a new version of an eye drop medicine. This new version is a 'generic' medicine, meaning it contains the same active ingredients as an existing eye drop called Combigan®. The two main ingredients are Brimonidine and Timolol, which work together to help lower pressure inside your eye.
Why is this important? Many people in the UK live with conditions like open-angle glaucoma or ocular hypertension. Both of these cause the pressure inside your eye to be too high, which can slowly damage the nerve connecting your eye to your brain. If this damage isn't stopped, it can lead to problems with your sight. Eye drops are a common way to manage this pressure and protect your vision. By comparing the new generic eye drop to the established one, we want to make sure it's just as effective and safe. If it is, this could provide another reliable and potentially more affordable treatment option for people needing these eye drops.
In simple terms, we want to confirm that switching to this new generic eye drop would give you the same benefits as the current one. This is a big step before new medicines can be approved for general use, making sure they meet all the necessary standards for patient care.
Key takeaways
- Compares a new generic eye drop to an existing one (Combigan®).
- Aims to check if the new eye drop is just as effective and safe.
- For adults with open-angle glaucoma or high eye pressure.
- Involves using eye drops for 12 weeks and having eye pressure checked.
- Could lead to a new, potentially more affordable, treatment option.
- Participation includes regular monitoring by eye specialists.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years or older. Both men and women can take part. The main conditions we're looking for are open-angle glaucoma or ocular hypertension.
Open-angle glaucoma is a common eye condition where the pressure inside your eye is too high. This high pressure can damage the optic nerve, which is like the cable that sends pictures from your eye to your brain. Ocular hypertension simply means you have high pressure in your eye, but without the nerve damage seen in glaucoma yet.
There will also be other specific health checks to make sure the study is right and safe for you. These will likely involve looking at your medical history, current health, and other medications you might be taking. Your eye doctor will be able to tell you more about all the exact 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 or high pressure in your eye (ocular hypertension)?
- Are you able to attend regular clinic visits for 12 weeks?
- Are you generally in good health otherwise, or is any other health condition well-controlled?
- Are you willing to use eye drops as directed for the study duration?
What does participation involve?
If you decide to take part in this study, you would be given eye drops to use. You would either receive the new generic eye drop or the existing Combigan® eye drop. Neither you nor your study doctor would know which one you are getting, to keep the results fair. You would need to use these drops regularly as instructed for a period of 12 weeks.
Throughout these 12 weeks, you would have several visits to the clinic. At these visits, doctors and nurses would carefully measure the pressure inside your eyes, typically at different times of the day (morning, midday, and afternoon). They would also check your overall eye health and ask about any effects you’ve noticed. The total duration of your active involvement in the study would be about 12 weeks, plus any initial assessment visits.
Potential risks and benefits
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Common questions
What is open-angle glaucoma?
It's an eye condition where high pressure inside the eye can damage the optic nerve, potentially leading to vision loss over time if not treated.
What does 'ocular hypertension' mean?
It means you have high pressure in your eye, but without the signs of nerve damage that doctors look for in glaucoma.
What's a 'generic' medicine?
A generic medicine contains the same active ingredients and works the same way as a brand-name medicine, but is usually less expensive.
Will I know which eye drops I'm getting?
No, to ensure fair results, neither you nor your study doctor will know whether you are receiving the new generic drops or the existing Combigan® drops.
How long will I be in the study?
The main treatment and monitoring period for this study is 12 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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