Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
RecruitingEyelid ptosis
Study on the Effectiveness and Safety of Oxymetazoline Hydrochloride Eye Drops for Adults with Acquired Blepharoptosis
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the treatment of acquired blepharoptosis, a condition where the upper eyelid droops over the eye, potentially affecting vision. The treatment being tested is an eye drop solution called STN1013800, which contains the active ingredient oxymetazoline hydrochloride. This medication is designed to be used twice daily to help lift the eyelid and improve vision.
The purpose of the study is to evaluate how effective and safe STN1013800 is in treating acquired blepharoptosis. Participants in the study will be randomly assigned to receive either the eye drops containing oxymetazoline hydrochloride or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for a period of 42 days, during which participants will use the eye drops and attend regular check-ups to monitor their progress.
Throughout the study, the main focus will be on measuring changes in the position of the eyelid and assessing any improvements in vision. The study aims to determine if the eye drops can effectively lift the eyelid and improve the quality of life for those with acquired blepharoptosis. Participants will be closely monitored for any side effects or changes in their condition to ensure the treatment is safe and beneficial.
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?
8 criteria
- Must be able to understand and sign a form agreeing to participate in the study before any study-related activities begin.
- Must be a male or female aged between 18 and 75 years.
- Must have a diagnosis of **acquired ptosis** (drooping of the upper eyelid) in both eyes, with a specific measurement called **MRD1** between 0 and 2 mm in the study eye. **MRD1** is the distance between the upper eyelid margin and the center of the pupil. Vision must be 20/80 or better in both eyes.
- Females must be either 1-year postmenopausal, surgically sterilized, or if of childbearing potential, must have a negative pregnancy test and use an acceptable form of birth control during the study. Acceptable methods include devices like an intrauterine device, hormonal methods like pills or patches, barrier methods like condoms, or abstinence.
- Male participants with a female partner who can have children should use a reliable birth control method, such as abstinence, condoms, or having had a vasectomy (a surgical procedure done at least 6 months before joining the study).
- Must be able to apply the study treatment themselves or have someone to help them apply it throughout the study.
- Must feel that the drooping eyelid is bothersome enough to want treatment for it.
- Must have a specific loss of vision in the upper part of the visual field, as determined by a reliable test called the **HVF 36-point ptosis protocol test**. If both eyes meet the criteria, the eye with the more severe drooping will be the study eye. If both eyes are the same, the right eye will be chosen. The test must be reliable, and if not, it must be repeated during the screening visit.
Who cannot join the trial?
8 criteria
- Patients who have any other eye condition that could affect the study results.
- Patients who have had surgery on their eyelids in the past 6 months.
- Patients who are currently using any medication that affects the eyes, unless they can stop using it during the study.
- Patients who have a known allergy to any ingredient in the study medication.
- Patients who are pregnant or breastfeeding.
- Patients who have participated in another clinical trial within the last 30 days.
- Patients who have a serious medical condition that could interfere with the study.
- Patients who are unable to follow the study instructions or attend all study visits.
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Verified & featuredResponsive Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
RecruitingWarsaw, PolandResponsive Leids Universitair Medisch Centrum (LUMC)
Leiden, The NetherlandsResponsive Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands
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Investigated drugs
STN1013800: This is an eye drop medication being tested for its effectiveness and safety in treating acquired blepharoptosis, a condition where the upper eyelid droops over the eye. The medication is applied twice daily to see if it can help lift the eyelid and improve vision.
What is already known about the treatment
Oxymetazoline HCl 0.1% Eye Drops – This medication is administered as eye drops and is applied directly to the eyes. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating acquired blepharoptosis, a condition characterized by drooping of the upper eyelid. The main therapeutic indication is to improve eyelid position in patients with this condition. At the molecular level, oxymetazoline works by stimulating alpha-adrenergic receptors, leading to muscle contraction and lifting of the eyelid. It is classified pharmacologically as an alpha-adrenergic agonist.
Investigated diseases
Acquired Blepharoptosis – This condition is characterized by the drooping of the upper eyelid, which can occur in one or both eyes. It is often due to the weakening or dysfunction of the muscles responsible for lifting the eyelid. Over time, the drooping can become more pronounced, potentially affecting vision if the eyelid covers the pupil. The condition can develop gradually or appear suddenly, depending on the underlying cause. It is more common in older adults but can occur at any age. The progression of the drooping can vary, with some individuals experiencing a slow change and others noticing a more rapid onset.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513356-15-00Protocol code101380003SAEstimated enrolment380 patientsSponsorSanten
sourced from the EU Clinical Trials Register and site verification
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