New eye drop aims to make pupil dilation quicker and easier
NCT ID NCT07075224
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new eye drop that combines two drugs—tropicamide and phenylephrine—to widen the pupil. It is being studied in 20 healthy adults and compared to an existing insert placed in the eye. The main goal is to see how well and how fast the drop works, and to check for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fixed combination of tropicamide 0.34% and phenylephrine hydrochloride 2.5% eye drops
- What this could lead to
- If successful, this could offer a faster, more comfortable alternative to current pupil-dilation methods for eye exams or surgeries.
- What could go wrong
- This is an early-phase trial with only 20 healthy volunteers, so results may not apply to patients with eye conditions. The drop may cause side effects like stinging or blurred vision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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20 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy volunteers of both genders, aged ≥18 at the time of signing the informed consent. * Healthy volunteers are declared healthy based on medical history, physical examination, ophthalmological examination, Electrocardiogram (ECG), within the stated normal range; a participant with a clinical abnormality or laboratory parameter(s) outside the reference range may be included if the investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or interpretation.. 3\. Females who participate in the study, that are at reproductive age agree to undergo pregnancy tests and to use a highly effective birth control method during the study. Exclusion Criteria: * Hypersensitivity to the active substances or to the excipients or related class of the medicinal product. Serious hypersensitivity reactions include angioedema, anaphylaxis and exfoliative skin conditions including Stevens-Johnson syndrome. * Clinically significant illness or surgery within four weeks prior IMP administration. * Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure \< 90 or \>140 mmHg, seated diastolic blood pressure \< 50 or \> 90 mmHg or heart rate less than 50 or over 100 bpm) at screening. History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma. * Clinically significant abnormal laboratory values. * Unwilling to discontinue use of contact lenses on the day of a treatment visit. * Current active eye disease (i.e. any disease for which topical or systemic ophthalmic medication is necessary). In case of historical eye disease, topical or systemic ophthalmic medication should have been stopped for at least one month before the study. * Pupillary abnormalities (irregular, very dark iris, iris synechiae, eye movement disorder (e.g. Nystagmus, etc.), dacryocystitis and all other pathologies of tears drainage system. * Use of any ophthalmic medication except unpreserved artificial tears on the day of a treatment visit. * History of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis). * History of ocular trauma, infection or inflammation within the last 3 months. * Ocular surgery or laser treatment of any kind in the study eye within 3 months. * Irregularly-shaped pupil secondary to ocular trauma, intraocular surgery or congenital defect. * History of neurogenic pupil disorder (e.g. Horner's syndrome, third cranial nerve palsy, Adie's pupil, Argyl Robertson syndrome, etc.). * History of iris surgery of any kind (e.g. iridotomy, iridectomy, coreoplasty). * History of previous corneal surgery; iris atrophy, traumatic mydriasis or angle recession, chronic or acute uveitis. * Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis). Pseudoexfoliation, exfoliative syndrome. * History of closed-angle glaucoma. * Subjects with narrow angle prone to glaucoma precipitated by mydriatics * Subject undergoing treatment identified as potentially interacting with the IMP, including antidepressant drugs, beta-blockers, other indirect sympathomimetics, alpha sympathomimetics (oral and/or nasal routes), dopaminergic ergot alkaloids, ergot alkaloid vasoconstrictors, selective MAOI-A, linezolid, and halogenated volatile anesthetics. -. Subject planning to receive an MAOI within 3 weeks following the end of the study. * Subjects who have received non-selective monoamine oxidase inhibitors (MAOIs) within the last 15 days
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Iaso Thessalia General Clinic Private Obstetrics S.A.
Larissa, 41000, Greece
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Ophthalmiatreion Athinon
Athens, 10672, Greece