Evaluation of a Novel Ocular Lubricating Eye Drop
This research is looking into a new eye drop, called ABR2, designed to help with dry eyes. The main goal is to find out if these drops are safe to use for a short time and if they help relieve the uncomfortable feeling often caused by dry eyes. The study has two parts. In the first part, a single drop of ABR2 will be given in one eye, and observations will be made for an hour. In the second part, participants will use ABR2 drops at least twice a day for 28 days. This study doesn't compare ABR2 to other treatments or a 'dummy' drop, it just focuses on how well ABR2 works on its own.
At a glance
What is this study about?
If you suffer from dry, uncomfortable eyes, you'll know how bothersome it can be. This study is testing a new eye drop called ABR2, which is designed to act as a lubricant, or moisturiser, for your eyes. The main reason for this study is to check if these new drops are safe to use and whether they can offer temporary relief from the dryness and discomfort you might experience.
The study is divided into two main sections. The first section involves a single dose of the ABR2 eye drop into one eye, and researchers will carefully watch how you respond over the course of about an hour. This helps them understand the immediate effects of the drops.
The second section involves using the ABR2 eye drops regularly over a longer period. You would use one drop at least twice a day for 28 days, though you could use them up to four times a day if you felt you needed to. This part helps researchers see if the drops continue to be safe and effective with daily use. It's important to know that this study is not comparing ABR2 to any other eye drops or a placebo (a 'dummy' treatment), but simply looking at the effects of ABR2 on its own.
Key takeaways
- This study evaluates a new eye drop (ABR2) for dry eyes.
- It aims to check the safety and comfort of the drops.
- Participation involves either a single dose or 28 days of use.
- You cannot wear contact lenses during the study.
- No placebo or other treatments are being compared.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and able to understand what the study involves and agree to take part. You'll also need to be able to follow instructions and come to all your appointments.
There are some specific requirements related to your eyes. For example, you shouldn't have worn contact lenses during the study period, and you shouldn't have other active eye conditions or infections apart from dry eye. You also can't have had certain eye surgeries, like laser eye surgery, in the last year. If you're allergic to any ingredients in the drops or to a common eye test dye, you wouldn't be able to participate.
Finally, if you've recently been part of another eye-related medical study (within the last 14 days) or if you're already using lubricating eye drops more than twice a day, you wouldn't be eligible for the second part of this 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 or older?
- Do you have dry eye symptoms?
- Have you avoided other eye studies in the last 14 days?
- Are you able to attend all scheduled appointments?
- Are you willing to not wear contact lenses for the study?
- Are you not allergic to fluorescein eye dye or any listed eye drop ingredients?
What does participation involve?
If you decide to take part, the amount of time you'll spend in the study depends on which part you're in. For Part 1, you'll have two visits: an initial check-up (screening) and then the treatment visit itself, where you'll spend about 3 hours in total.
For Part 2, there are more visits spread out over 28 days. You'll have an initial check-up, a visit to start using the drops, and then follow-up appointments after 3 days, 1 week, 2 weeks, and 4 weeks. In total, these visits will add up to about 6.5 hours of your time.
During these visits, researchers will assess your eyes and ask you questions about how you're feeling and your an eye comfort. You will be given the ABR2 eye drops to use as directed. It's very important that you remove contact lenses and don't wear them for the entire study period if you're taking part.
Potential risks and benefits
Locations (1)
- Centre for Ocular Research & Education, School of Optometry & Vision Science, University of WaterlooVerified postcodeWaterloo, Canada· Recruiting
Common questions
What is 'Dry Eye Syndrome'?
Dry Eye Syndrome is a common condition where your eyes don't produce enough tears, or the tears evaporate too quickly, leading to discomfort, stinging, or gritty feelings.
What are 'ocular lubricating eye drops'?
These are special eye drops designed to moisten and soothe your eyes, similar to how moisturiser works on dry skin, to help relieve dryness and irritation.
Will I get a 'dummy' drop (placebo)?
No, this study only tests the ABR2 eye drops. You will not receive a placebo or a different type of eye drop for comparison.
How long will I be using the eye drops?
If you are in Part 1 of the study, it's just a single dose. If you are in Part 2, you will use the drops for 28 days.
Can I wear my contact lenses during the study?
No, if you join the study, you will need to stop wearing contact lenses for the entire study period.
How to find out more
CORE Studies
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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