Study of eye drops containing tropicamide and phenylephrine hydrochloride for pupil dilation in healthy volunteers

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What is this study about?

This study examines two eye medications used for pupil dilation (widening of the pupil) before surgery or for diagnostic eye examinations. The study compares a new eye drop solution containing a combination of tropicamide and phenylephrine hydrochloride against Mydriasert, which is an existing eye insert containing the same active substances.

The purpose of the study is to evaluate how effectively the new combination eye drops work in dilating the pupil compared to the currently available eye insert. The study will also assess how safe the new medication is when used in healthy volunteers. The main focus will be on measuring changes in pupil size over time after the medication is applied to the eye.

During the study, participants will receive either the new combination eye drops or the eye insert. The study will monitor how quickly and effectively the pupils dilate, and how long the effect lasts. Throughout the 6-hour observation period, researchers will take photographs of the pupils and record any discomfort or other effects experienced by the participants. The study will also track how long it takes for pupils to return to their normal size.

1 initial examination

You will undergo a medical and eye examination to confirm your eligibility for the study

The examination includes: physical check-up, ophthalmological examination, and heart rhythm test (ECG)

2 eye drop administration

You will receive either:

– IMP 08P2002F0 eye drops (containing 0.34% tropicamide and 2.5% phenylephrine hydrochloride), or

– Mydriasert (ophthalmic insert)

The medication will be applied to dilate your pupils

3 monitoring period

Your pupil size will be measured through photographs at specific intervals:

– Every 10-15 minutes during the first 1.5 hours

– Every 30 minutes from 2 to 6 hours after application

Your comfort level will be assessed at: 10 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours

4 final measurements

The study concludes after 6 hours of monitoring

Your pupils will be checked to ensure they return to their normal size

Any side effects other than pupil dilation will be recorded

5 safety monitoring

Throughout the study, you will be monitored for any unwanted effects

Any eye-related symptoms will be documented

The total duration of your participation is one day

Who Can Join the Study?

Must be at least 18 years old at the time of signing the consent form
Must be in good health, confirmed by:
– Medical history review
– Physical examination
– Eye examination
– Heart test (ECG – electrical recording of heart activity)
Can participate with minor health issues if the study doctor determines they won’t affect study safety or results
For women of childbearing age:
– Must agree to pregnancy testing
– Must use highly effective birth control during the study (such as birth control pills, implants, IUD, or having a partner with vasectomy)
– Women are considered of childbearing age if they have menstrual periods and haven’t been period-free for 12 continuous months
Must be able to understand and follow study procedures and restrictions as determined by the study doctor
Must read and sign the Informed Consent Form before starting the study

Who Cannot Join the Study?

Known hypersensitivity or allergy to tropicamide, phenylephrine, or any other components of the eye drops
History of narrow-angle glaucoma (a serious eye condition where pressure inside the eye rises quickly)
Active eye inflammation or infection
Severe heart or blood pressure conditions
Current use of medications that could interact with the study medication
Pregnant women or those planning pregnancy during the study period
Breastfeeding mothers
Participation in another clinical trial within the past 30 days
Any condition that could affect pupil dilation or response to eye medications
Inability to follow study procedures or attend follow-up visits
History of serious eye trauma or surgery in the past 3 months
Wearing contact lenses that cannot be removed for the study
Uncontrolled diabetes (high blood sugar levels that are not well managed)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Iaso Thessalia General Clinic Private Obstetrics S.A.	Larissa	Greece
Obbluxidrxwvppoc Alpmdwq	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.03.2025

Trial locations

Investigated drugs:

IMP 08P2002F0 is an eye drop solution that combines two medications used to dilate the pupil of the eye. It contains tropicamide and phenylephrine hydrochloride. This combination medication helps to widen the pupils, which is often needed for eye examinations or procedures.

Tropicamide is a medication that temporarily widens (dilates) the pupil and relaxes the muscles that help your eye focus. It belongs to a group of drugs called anticholinergics.

Phenylephrine is a medication that also dilates the pupil by stimulating specific muscles in the eye. It belongs to a group of medications called alpha-adrenergic agonists.

Mydriasert is a commercially available eye insert that contains similar active ingredients and is used as a comparison medication in this study. It is also used for pupil dilation during eye examinations.

Insufficient pupillary dilation – A condition where the eye’s pupil does not expand adequately in response to normal stimuli or medical needs. The pupil, which is the black center part of the eye, naturally changes size to control how much light enters the eye. In this condition, the pupil remains smaller than required for medical procedures or examinations. This state can occur naturally or may need to be addressed before eye surgeries and detailed eye examinations.

Miosis – A condition characterized by excessive constriction or abnormal smallness of the pupil of the eye. The pupil remains in a contracted state, limiting the amount of light that enters the eye. This condition can be physiological (normal response to light) or pathological (caused by underlying conditions). Miosis can affect one or both eyes and may interfere with normal vision in low-light conditions.

Trial ID:

2024-517456-35-00

Protocol code:

UP-CLI-2023-01

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of eye drops containing tropicamide and phenylephrine hydrochloride for pupil dilation in healthy volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?