A 4-Week, Phase II, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study With 4 Weeks of Follow-Up to Evaluate Safety and Efficacy of a new formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution at two different Concentrations in patients with Dry Eye Disease (REDUCO study)
This research study is looking into a new eye drop treatment for people suffering from dry eye disease. The eye drop contains a man-made version of something our bodies naturally produce, called 'nerve growth factor'. The main goal is to find out if this new eye drop can help improve dry eye symptoms like discomfort and irritation within 8 weeks. Researchers will also check how safe the new eye drop is and how it affects other aspects of eye health, such as tear production and the surface of the eye. Participants will be monitored for 4 weeks after the main treatment period ends to see how they are doing. This is an early-stage study to understand if the treatment works and is safe.
At a glance
What is this study about?
This study, called REDUCO, is investigating a new eye-drop treatment for people with dry eye disease. If you have dry eyes, you know the discomfort this can cause. The study is particularly interested in whether a new medicine, which is a man-made copy of a natural substance called 'nerve growth factor', can help. This substance plays a role in keeping our nerves healthy, and researchers believe it might help improve the health of the eye's surface and reduce dry eye symptoms.
Participants in the study will be given different versions of the eye drop. Some will receive the new medicine at two different strengths, and others will receive a 'placebo'. A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. This helps researchers compare the effects of the new medicine against no treatment to see if it's truly making a difference. The study is 'double-masked', meaning neither you nor your study doctor will know which treatment you are receiving, which ensures fair and unbiased results.
The main aim is to see how much dry eye symptoms improve through special questionnaires after 8 weeks. Researchers will also look at other things like how well your eyes produce tears, the health of the front surface of your eye, and how your quality of life is affected. Your safety will be closely monitored throughout the study.
Key takeaways
- The study is testing a new eye drop for dry eye disease.
- It uses a man-made version of a natural body substance.
- The study lasts 12 weeks in total, with 8 weeks of treatment and 4 weeks of follow-up.
- You might receive the new medicine or a dummy treatment (placebo).
- Your symptoms and eye health will be closely monitored.
- You can leave the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part.
There will be other specific requirements to ensure the study is right for you and that the results are clear. For example, you might need to have a certain level of dry eye symptoms that affect your daily life, and you shouldn't have other serious eye conditions that could interfere with the results.
The study team will review your medical history and perform some eye tests to make sure you fit all the necessary criteria for the study.
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?
- Do you currently have dry eye disease?
- Are you comfortable with regular eye exams and clinic visits?
- Do you understand you might receive a dummy treatment?
- Do you feel you can commit to the study's schedule?
What does participation involve?
If you join the study, you'll be involved for a total of 12 weeks. For the first 8 weeks, you will use the assigned eye drops. These eye drops are prepared from a powder that is mixed with a special liquid right before use. Some participants will receive the active study drug, others will receive a dummy treatment (placebo). There will be regular visits to the clinic for eye checks and to ask about your symptoms and any side effects. After the 8-week treatment period, there will be a 4-week follow-up period to see how you are doing after stopping the eye drops. During this time, you'll still have some clinic visits for monitoring.
Potential risks and benefits
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Common questions
What is dry eye disease?
Dry eye disease is a common condition where your eyes don't produce enough tears, or the tears evaporate too quickly, leading to discomfort, irritation, and sometimes blurred vision.
What is 'nerve growth factor'?
'Nerve growth factor' is a natural substance in your body that helps keep nerves healthy. Researchers are looking at a man-made version to see if it can help with dry eyes.
What does 'double-masked' mean?
It means that neither you nor your study doctor will know whether you are receiving the active study drug or the dummy treatment (placebo). This helps keep the study fair.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related treatments and assessments are usually provided free of charge.
What is a 'placebo'?
A placebo is adummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the new medicine is actually working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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