Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Pharmacodynamics of IMP 08P2002F0 (Fixed dose combination of 0.34% tropicamide and 2.5% phenylephrine hydrochloride, eye drop, Solution) a new ophthalmic mydriatic solution in healthy volunteers.

This research is looking at new eye drops that make your pupils (the black part in the centre of your eye) get bigger. This is often needed before eye examinations or certain eye surgeries. The study aims to find out how well these new drops work compared to existing treatments, how quickly they start to make your pupils bigger, and how long this effect lasts. Researchers will also be checking for any side effects and how comfortable the drops are. We are looking for healthy adult volunteers to help test these new eye drops to ensure they are safe and effective for future use.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Unither Pharmaceuticals

Enrolment target

Start

16 Jun 2025

to obtain pre-operative mydriasis or for diagnostic purposes

What is this study about?

This study is investigating a new type of eye drop that helps to widen your pupils. Widening the pupils, a process called 'mydriasis', is a common procedure needed by eye doctors. It allows them to get a better view of the back of your eye, which is very important for checking your eye health or before certain eye operations like cataract surgery.

The new eye drops contain a specific mix of two medicines: tropicamide and phenylephrine hydrochloride. Researchers want to compare these new drops to a standard treatment called Mydriasert and also to a simple saltwater solution (sodium chloride). By doing this, they can figure out if the new drops are more effective, faster-acting, or have fewer side effects than what's currently available.

The main goal of the study is to see how much the pupils change in size within 60 minutes after using the drops. They'll take photos of the pupils to measure this accurately. Scientists will also track how long it takes for the pupils to reach a certain size, how long they stay dilated, and when they return to normal. This research is important because it could lead to better, more comfortable options for patients needing their pupils widened in the future.

Key takeaways

This study tests new eye drops to widen pupils for exams or surgery.
It aims to find out how well and quickly the drops work, and how long they last.
Healthy adults aged 18 and over are wanted to take part.
Participation involves eye drop application, pupil measurements (photos), and checking for comfort.
Your vision will likely be blurry and light-sensitive afterwards. You will need someone to drive you home.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means we are inviting both men and women who are 18 years old or older. There is no upper age limit for joining, as long as you are considered healthy.

To be eligible, you wouldn't have any major ongoing eye conditions or other significant health problems that might affect the study results or your safety. The research team will do some checks to make sure you're a good fit 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?
Are you considered generally healthy?
Do you have no significant ongoing eye problems?
Are you willing to have eye drops put into your eyes?
Are you happy for researchers to take photos of your pupils?
Are you able to attend appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several assessments. After initially checking your eye health, you will receive either the new eye drops, the standard Mydriasert treatment, or simple saline solution in your eye, depending on which group you are assigned to. For a clearer comparison, a simple saline solution (salt water) might be used in the other eye.

Throughout the study, researchers will regularly take photographs of your pupils to measure how much they widen and how long they stay dilated. These measurements will occur at various times, starting just 10 minutes after receiving the drops and continuing for up to 6 hours. You might also be asked about any discomfort you feel at different points. The study involves a single day for the main part of the assessment.

Potential risks and benefits

Participating in this study will help develop potentially better eye drops for future patients needing pupil dilation, which is a key benefit. You will also receive careful medical monitoring during your time in the study. Potential risks include temporary blurry vision and light sensitivity due to pupil dilation, and possibly some temporary discomfort from the drops, similar to what you might experience with eye drops from an optician. Serious side effects are rare. Remember, you can withdraw from the study at any time without giving a reason, and it will not affect any future medical care you receive.

Locations (1)

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

—
Unverified
Greece

Common questions

What does 'widening my pupils' mean?

It means the black circle in the centre of your eye will get bigger, letting in more light. This allows eye doctors to see the back of your eye more clearly.

Will my vision be blurry after the drops?

Yes, it's very likely your vision will be blurry and you might be sensitive to light while your pupils are dilated. This is a normal effect of these types of eye drops.

How long will my pupils stay wide?

The study will specifically measure this, but typically, drops that widen pupils can last for several hours, sometimes up to a full day.

Is this a new medicine not used before?

The specific combination in these new drops is being tested, but the individual ingredients (tropicamide and phenylephrine) are commonly used in eye care already.

Do I have to do anything special before coming?

The research team will give you specific instructions, but generally, you should avoid wearing contact lenses on the day of the study. You'll likely need someone to drive you home afterwards.