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.

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

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

Study Overview

• Status: Recruiting
• Conditions: Acquired Blepharophimosis
• Intervention / Treatment: Drug: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers; Other: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

Detailed Description

This is a randomised, double-masked, placebo-controlled Phase 3 study of the safety and efficacy of STN1013800 in the treatment of acquired blepharoptosis.

Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. Approximately 234 adult subjects with blepharoptosis who meet all the eligibility criteria will be randomised in a 1:1 ratio to receive:

• STN1013800 BID
• Placebo BID

Note that:

• On study visits Day 1 and Day 42, the AM dose is administered at 08:00 (at site) and the PM dose is administered at 16:00 (self-administered at home)
• On study visit Day 14, the AM dose is administered at 06:00 (self-administered at home), the PM dose is administered at 14:00 (at site)

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Santen SAS Clinical Operations; Phone Number: +31 683 667 357; Email: edith.vandijkman@santen.com

Study Locations

• Czechia
  • Pardubice, Czechia, 530 02
    • Recruiting
    • Oftex.s.r.o, oční klinika
    • Contact: Dr Vladimir Korda
  • Pilsen, Czechia
    • Recruiting
    • Fakultni nemocnice Plzeň, Oční oddělení
    • Contact: Dr Štěpán Rusňák
  • Prague, Czechia, 140 59
    • Recruiting
    • Fakultni Thomayerova nemocnice
    • Contact: Dr Katerina Myslik Manethova
• France
  • Bordeaux, France, 33100
    • Recruiting
    • Clinique Ophtalmologique Thiers
    • Contact: Dr Olivier Galatoire
  • Guillon, France, 35000
    • Recruiting
    • CHU Rennes - PONTCHAILLOU Service ophtalmologie
    • Contact: Prof. Frédéric Mouriaux
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Contact: Dr Marie Callet
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie
    • Contact: Prof. Philippe Gain
• Germany
  • Goettigen, Germany, 37075
    • Recruiting
    • Unversitaetsmedizin Goettingen
    • Contact: Dr Michael Schittkowski
  • Göttingen, Germany, 37075
    • Recruiting
    • Universitätsmedizin Göttingen; Georg-August-Universität
    • Contact: Prof. Dr. Michael Schittkowski
• Hungary
  • Budapest, Hungary
    • Recruiting
    • Észak-Pesti Centrumkórház - Honvédkórház
    • Contact: Dr Gábor Vogt
  • Budapest, Hungary
    • Recruiting
    • Budapest Retina Associates
    • Contact: Dr. Seres András
  • Budapest, Hungary
    • Recruiting
    • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
    • Contact: Dr. Czumbel Norbert
  • Debrecen, Hungary
    • Recruiting
    • Debreceni Egyetem Klinikai Kozpont
    • Contact: Dr. Vajas Attila
  • Pécs, Hungary
    • Recruiting
    • Ganglion Orvosi Központ - Nozologen Kft.
    • Contact: Dr. Varsányi Balázs
• Italy
  • Ferrara, Italy, 44124
    • Recruiting
    • AOU di Ferrara, Arcispedale Sant'Anna
    • Contact: Dr Mura Marco
  • Naples, Italy, 80131
    • Recruiting
    • AOU Federico II
    • Contact: Dr Strianese Diego
  • Roma, Italy, 00168
    • Recruiting
    • PU A. Gemelli, Università Cattolica del Sacro Cuore
    • Contact: Dr Savino Gustavo
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Recruiting
    • Leiden University Center (LUMC)
    • Contact: Dr Stijn Van der Meeren
  • Rotterdam, Netherlands, 3011 BH
    • Recruiting
    • Oogziekenhuis Rotterdam
    • Contact: Dr Dion Paridaens
• Poland
  • Gdansk, Poland
    • Recruiting
    • Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
    • Contact: Dr Krystyna Raczynska
  • Katowice, Poland, 40-594
    • Recruiting
    • Gabinet Okulistyczny Prof. Edward Wylegala
    • Contact: Dr Adam Wylegala
  • Warsaw, Poland, 02-507
    • Recruiting
    • Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki
    • Contact: Dr Larysa Krajewska-Weglewicz
  • Warsaw, Poland, 04-141
    • Recruiting
    • Military Institute of Medecine - National Institute of Research
    • Contact: Dr Izabela Nowak-Gospodarowicz
• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Dr Santiago Ortiz Pérez
  • Granada, Spain, 18014
    • Recruiting
    • Virgen de las Nieves University Hospital
    • Contact: Dr Santiago Ortiz-Perez
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
    • Contact: Dr Marco Sales Sanz
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón y Caja
    • Contact: Dr Marco Sanz
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Complexo Hospitalario Universitario De Santiago
    • Contact: Dr José Manuel Abalo Lojo
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
    • Contact: Dr Laura Gil Arribas
  • Zaragoza, Spain, 50009
    • Recruiting
    • Miguel Servet University Hospital
    • Contact: Dr Laura Gil Arribas
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust, St James's University Hospital
    • Contact: Prof. Bernard Chang
  • London, United Kingdom, EC1V 2PD
    • Recruiting
    • Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital
    • Contact: Dr. Daniel Ezra
  • London, United Kingdom, W1G 8QL
    • Recruiting
    • FaceRestoration Ltd
    • Contact: Dr Rachna Murthy
  • London, United Kingdom, W8 5JN
    • Recruiting
    • Opal Clinic London Ltd
    • Contact: Dr Nikhil Cascone
  • Sunderland, United Kingdom, SR2 9HP
    • Recruiting
    • South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary
    • Contact: Mrs Adriana
  • Sunderland, United Kingdom
    • Recruiting
    • South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary
    • Contact: Dr. Adriana Chilinska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers	Drug: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers; STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
Placebo Comparator: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers	Other: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers; Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose.	Change from baseline in MRD1 (Marginal Reflex Distance, Distance from the centre of the pupil to central upper lid margin) on Day 14 at 4 hours after PM dose. This is to evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14	Day 14 at 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose	To assess the degree of improvement experienced by subjects since start of the trial (PRO)	Day 14 at 4 hours

Collaborators and Investigators

• Sponsor: Santen SAS

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Eyelid Diseases; Eye Abnormalities; Blepharoptosis; Blepharophimosis; Pharmaceutical Solutions; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Imidazoles; Solutions; Specialty Uses of Chemicals; Ophthalmic Solutions; Oxymetazoline
• Other Study ID Numbers: 101380003SA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No