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 | Recruiting Phase 3

• 1 other identifier: 101380003SA
• Study Type: interventional
• Target: 234
• Locations: 9 countries
• Sites: 36

Brief 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

Conditions

Acquired Blepharophimosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose

  Day 14 at 4 hours

Study Arms (2)

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

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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

Interventions

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 (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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
• 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.

You may not qualify if:

• In either eye:
• Congenital ptosis.
• Presence of either of the following:
• Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
• 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.

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (36)

Oftex.s.r.o, oční klinika

Pardubice, 530 02, Czechia

RECRUITING

Fakultni nemocnice Plzeň, Oční oddělení

Pilsen, Czechia

RECRUITING

Fakultni Thomayerova nemocnice

Prague, 140 59, Czechia

RECRUITING

Clinique Ophtalmologique Thiers

Bordeaux, 33100, France

RECRUITING

CHU Rennes - PONTCHAILLOU Service ophtalmologie

Guillon, 35000, France

RECRUITING

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie

Saint-Etienne, 42055, France

RECRUITING

Unversitaetsmedizin Goettingen

Goettigen, 37075, Germany

RECRUITING

Universitätsmedizin Göttingen; Georg-August-Universität

Göttingen, 37075, 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, 44124, Italy

RECRUITING

AOU Federico II

Naples, 80131, Italy

RECRUITING

PU A. Gemelli, Università Cattolica del Sacro Cuore

Roma, 00168, Italy

RECRUITING

Leiden University Center (LUMC)

Leiden, 2333 ZA, Netherlands

RECRUITING

Oogziekenhuis Rotterdam

Rotterdam, 3011 BH, Netherlands

RECRUITING

Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM

Gdansk, Poland

RECRUITING

Gabinet Okulistyczny Prof. Edward Wylegala

Katowice, 40-594, Poland

RECRUITING

Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki

Warsaw, 02-507, Poland

RECRUITING

Military Institute of Medecine - National Institute of Research

Warsaw, 04-141, Poland

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Virgen de las Nieves University Hospital

Granada, 18014, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Ramón y Caja

Madrid, 28034, Spain

RECRUITING

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Miguel Servet University Hospital

Zaragoza, 50009, Spain

RECRUITING

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

Leeds, LS9 7TF, United Kingdom

RECRUITING

Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

RECRUITING

FaceRestoration Ltd

London, W1G 8QL, United Kingdom

RECRUITING

Opal Clinic London Ltd

London, W8 5JN, United Kingdom

RECRUITING

South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

RECRUITING

South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary

Sunderland, United Kingdom

RECRUITING

MeSH Terms

Interventions

Oxymetazoline; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Santen SAS Clinical Operations

CONTACT

+31 683 667 357; edith.vandijkman@santen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double -masked study with subjects, Investigators, Site Staff, Reading Centre personnel, and Santen personnel involved in the conduct of the study all masked to the study treatment. Each eligible subject will receive a numbered study treatment kit assigned by central randomisation via IWRS at Baseline.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. This study will consist of a screening period of up to 8 days, a 6-week double-masked treatment period, and a post-treatment visit 2 weeks after the last administration of the study drug.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 23, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

GB (6); DE (2); PL (4); IT (3); FR (4); ES (7); NL (2); HU (5); CZ (3)