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Clinical Trials in the UK / NCT06514612
Recruiting Phase 3

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.

NCT06514612 · tracked via the Priya Life Science UK tracker
Sponsor
Santen SAS
Phase
Phase 3
Started
2024-12-30
Last updated
2026-05-04

Condition(s) studied

Acquired Blepharophimosis

Investigational drug(s) / intervention(s)

STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containersPlacebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers

Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

Study summary

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Oftex.s.r.o, oční klinika Pardubice Czechia Recruiting
Fakultni nemocnice Plzeň, Oční oddělení Pilsen Czechia Recruiting
Fakultni Thomayerova nemocnice Prague Czechia Recruiting
Clinique Ophtalmologique Thiers Bordeaux France Recruiting
CHU Rennes - PONTCHAILLOU Service ophtalmologie Guillon France Recruiting
Hôpital Fondation Adolphe de Rothschild Paris France Recruiting
CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie Saint-Etienne France Recruiting
Unversitaetsmedizin Goettingen Goettigen Germany Recruiting
Universitätsmedizin Göttingen; Georg-August-Universität Göttingen Germany Recruiting
Budapest Retina Associates Budapest Hungary Recruiting
Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet Budapest Hungary Recruiting
Észak-Pesti Centrumkórház - Honvédkórház Budapest Hungary Recruiting
Debreceni Egyetem Klinikai Központ Debrecen Hungary Recruiting
Ganglion Orvosi Központ - Nozologen Kft. Pécs Hungary Recruiting
AOU di Ferrara, Arcispedale Sant'Anna Ferrara Italy Recruiting
AOU Federico II Naples Italy Recruiting
PU A. Gemelli, Università Cattolica del Sacro Cuore Roma Italy Recruiting
Leiden University Center (LUMC) Leiden Netherlands Recruiting
Oogziekenhuis Rotterdam Rotterdam Netherlands Recruiting
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM Gdansk Poland Recruiting
Gabinet Okulistyczny Prof. Edward Wylegala Katowice Poland Recruiting
Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki Warsaw Poland Recruiting
Military Institute of Medecine - National Institute of Research Warsaw Poland Recruiting
Hospital Universitario Virgen de las Nieves Granada Spain Recruiting
Virgen de las Nieves University Hospital Granada Spain Recruiting
Hospital Universitario Ramón y Cajal Madrid Spain Recruiting
Hospital Universitario Ramón y Caja Madrid Spain Recruiting
Complexo Hospitalario Universitario de Santiago Santiago de Compostela Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Recruiting
Miguel Servet University Hospital Zaragoza Spain Recruiting
Leeds Teaching Hospitals NHS Trust, St James's University Hospital Leeds United Kingdom Recruiting
Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital London United Kingdom Recruiting
FaceRestoration Ltd London United Kingdom Recruiting
Opal Clinic London Ltd London United Kingdom Recruiting
South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary Sunderland United Kingdom Recruiting
South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary Sunderland United Kingdom Recruiting

More Santen SAS trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06514612 on ClinicalTrials.gov ↗ ← All trials in the UK