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Eye drops could replace surgery for droopy eyelids

NCT ID NCT06514612

Symptom relief Sponsor: Santen SAS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether oxymetazoline eye drops can safely lift droopy eyelids (acquired blepharoptosis) in 234 adults. Participants use the drops twice daily for 14 days. The main goal is to measure how much the eyelid lifts, and patients will also report if they feel improvement. If successful, it may provide a drug alternative to eyelid surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxymetazoline hydrochloride 0.1% eye drops
What this could lead to
If it works, this could offer a non-surgical option to temporarily lift droopy eyelids, improving vision and appearance.
What could go wrong
This is a Phase 3 trial, but the effect is temporary (requires twice-daily drops) and may not work for everyone. Side effects like eye irritation or redness are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * Able to understand and sign an informed consent form prior to participation in any studyrelated procedures. * Male or female subjects ≥ 18 years and ≤ 75 years. * Presence of all the following at Screening: 1. diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye 2. Snellen VA of 20/80 or better in both eyes Note: MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD0 is defined as the upper eye lid margin at the centre of the pupil. Measurement of MRD1 will be done by a Central Reading Centre. If the centre of the pupil cannot be determined by the Central Reading Centre due to negative MRD1, the subject will be deemed ineligible. * Females who are 1-year postmenopausal, surgically sterilised, or females of childbearing potential with a negative urine pregnancy test at screening (Visit 1). Females of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. * A male subject with a female partner of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF and beginning screening), or other contraception deemed adequate by the investigator during the study. * Able to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period. * An answer of 'Yes' to the question 'Does the ptosis cause enough burden to the subject to want to receive treatment for it'. * Loss of ≥ 8 points not seen at or above 10° from fixation in the superior visual field of a reliable HVF 36-point ptosis protocol test at screening visit in the same eye with MRD1 ≥0 and ≤ 2 mm. If both eyes have MRD1 ≥0 and ≤ 2 mm the more ptotic eye (the eye with the smaller MRD1 measurement) will be the study eye. If the MRD1 is the same in both eyes, the eye with the worse VF will be the study eye. If the MRD1 and VF is the same in both eyes, the right eye will be the study eye. The HVF Analyzer will determine if the visual field test is reliable. If the HVF Analyzer issues an "XX" for fixation losses, false positives, and/or false negatives, the test will be deemed unreliable. If deemed unreliable, the test must be retaken once per scheduled screening visit. If a reliable visual field cannot be obtained, the subject will be a screen failure. Exclusion Criteria: * In either eye: * Congenital ptosis. * Presence of either of the following: 1. Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or 2. Dermatochalasis that extends less than 3 mm above the upper eyelid margin. * Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy). * Myogenic ptosis. * Marcus Gunn jaw-winking syndrome. * Previous ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening \[Visit 1\]). * Lid position affected by lid or conjunctival scarring. * Visual field loss from any cause other than ptosis. * History of herpes keratitis. * Poor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement. * History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1). * Facial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study. * Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study. * Mechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos. * Use of topical ophthalmic medications including anti-allergy \[e.g., antihistamines\], dry eye medications \[e.g., IKERVIS®\] (except artificial tears with anticipated stable usage during the study), antimicrobial drugs \[e.g., antibiotics and antivirals\], and anti-inflammatory drugs \[including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids\] within 8 days prior to screening (Visit 1) and during the study. Timolol maleate, or sympathetic alpha receptor agonists (e.g., brimonidine tartrate, or apraclonidine hydrochloride) for the treatment of elevated intraocular pressure. Please note that topical ophthalmic prostaglandin analogues for the treatment of elevated intraocular pressure are permitted if dosed in the evening in accordance with the approved prescribing information. All other topical antiglaucoma medications are prohibited. * Any intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit 1\) and during the study. * Current punctal plugs or placement of punctal plugs during the study. * Current use of OTC vasoconstrictor/decongestant eye medication (e.g., Visine® L.R.®) or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products (e.g., Afrin®) at any time during the study, (artificial tears are allowed). * Monoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).

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Conditions

The condition(s) this trial relates to.

blepharophimosis ptosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired blepharophimosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Federico II

    RECRUITING

    Naples, 80131, Italy

  • AOU di Ferrara, Arcispedale Sant'Anna

    RECRUITING

    Ferrara, 44124, Italy

  • Budapest Retina Associates

    RECRUITING

    Budapest, Hungary

  • Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

    RECRUITING

    Budapest, Hungary

  • CHU Rennes - PONTCHAILLOU Service ophtalmologie

    RECRUITING

    Guillon, 35000, France

  • CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie

    RECRUITING

    Saint-Etienne, 42055, France

  • Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki

    RECRUITING

    Warsaw, 02-507, Poland

  • Clinique Ophtalmologique Thiers

    RECRUITING

    Bordeaux, 33100, France

  • Complexo Hospitalario Universitario de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Debreceni Egyetem Klinikai Központ

    RECRUITING

    Debrecen, Hungary

  • FaceRestoration Ltd

    RECRUITING

    London, W1G 8QL, United Kingdom

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 140 59, Czechia

  • Fakultni nemocnice Plzeň, Oční oddělení

    RECRUITING

    Pilsen, Czechia

  • Gabinet Okulistyczny Prof. Edward Wylegala

    RECRUITING

    Katowice, 40-594, Poland

  • Ganglion Orvosi Központ - Nozologen Kft.

    RECRUITING

    Pécs, Hungary

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Caja

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hôpital Fondation Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

  • Leeds Teaching Hospitals NHS Trust, St James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Leiden University Center (LUMC)

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Miguel Servet University Hospital

    RECRUITING

    Zaragoza, 50009, Spain

  • Military Institute of Medecine - National Institute of Research

    RECRUITING

    Warsaw, 04-141, Poland

  • Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital

    RECRUITING

    London, EC1V 2PD, United Kingdom

  • Oftex.s.r.o, oční klinika

    RECRUITING

    Pardubice, 530 02, Czechia

  • Oogziekenhuis Rotterdam

    RECRUITING

    Rotterdam, 3011 BH, Netherlands

  • Opal Clinic London Ltd

    RECRUITING

    London, W8 5JN, United Kingdom

  • PU A. Gemelli, Università Cattolica del Sacro Cuore

    RECRUITING

    Roma, 00168, Italy

  • Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM

    RECRUITING

    Gdansk, Poland

  • South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary

    RECRUITING

    Sunderland, United Kingdom

  • South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary

    RECRUITING

    Sunderland, SR2 9HP, United Kingdom

  • Universitätsmedizin Göttingen; Georg-August-Universität

    RECRUITING

    Göttingen, 37075, Germany

  • Unversitaetsmedizin Goettingen

    RECRUITING

    Goettigen, 37075, Germany

  • Virgen de las Nieves University Hospital

    RECRUITING

    Granada, 18014, Spain

  • Észak-Pesti Centrumkórház - Honvédkórház

    RECRUITING

    Budapest, Hungary