Study of eye drops containing tropicamide and phenylephrine hydrochloride for pupil dilation in healthy volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- 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 trial?
13 criteria
- 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)
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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.
What is already known about the treatment
Tropicamide
A synthetic anticholinergic medication administered as eye drops that causes pupil dilation (mydriasis) and paralysis of eye focusing (cycloplegia). It works by blocking acetylcholine receptors in the eye muscles, which is commonly used for pre-operative preparation and eye examinations. This medication belongs to the class of antimuscarinic agents and typically begins working within 20-40 minutes of administration, with effects lasting several hours.
Phenylephrine hydrochloride
An alpha-adrenergic receptor agonist used as eye drops to dilate the pupil by stimulating muscles in the iris. It is frequently used in combination with other mydriatic agents for eye examinations and before eye surgery. The medication works by activating alpha-1 receptors in the eye muscles, causing pupil dilation without affecting focusing ability, and belongs to the sympathomimetic amine class of drugs.
IMP 08P2002F0
A novel fixed-dose combination eye drop solution containing 0.34% tropicamide and 2.5% phenylephrine hydrochloride, designed to achieve optimal pupil dilation for pre-operative and diagnostic purposes. This combination leverages the complementary mechanisms of action of both medications to provide effective mydriasis, potentially offering improved convenience and efficacy compared to individual medications or existing combinations.
Investigated diseases
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.
sourced from the EU Clinical Trials Register and site verification
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