RecruitingPhase 3NCT06514612

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

Sponsor

Santen SAS

Enrollment

234 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

Acquired Blepharophimosis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers and a drug called STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers for people with acquired blepharophimosis. The study is currently recruiting participants at 36 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers

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

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

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

Locations(36)

Oftex.s.r.o, oční klinika

Pardubice, Czechia

Fakultni nemocnice Plzeň, Oční oddělení

Pilsen, Czechia

Fakultni Thomayerova nemocnice

Prague, Czechia

Clinique Ophtalmologique Thiers

Bordeaux, France

CHU Rennes - PONTCHAILLOU Service ophtalmologie

Guillon, France

Hôpital Fondation Adolphe de Rothschild

Paris, France

CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie

Saint-Etienne, France

Unversitaetsmedizin Goettingen

Goettigen, Germany

Universitätsmedizin Göttingen; Georg-August-Universität

Göttingen, Germany

Budapest Retina Associates

Budapest, Hungary

Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

Budapest, Hungary

Észak-Pesti Centrumkórház - Honvédkórház

Budapest, Hungary

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary

Ganglion Orvosi Központ - Nozologen Kft.

Pécs, Hungary

AOU di Ferrara, Arcispedale Sant'Anna

Ferrara, Italy

AOU Federico II

Naples, Italy

PU A. Gemelli, Università Cattolica del Sacro Cuore

Roma, Italy

Leiden University Center (LUMC)

Leiden, Netherlands

Oogziekenhuis Rotterdam

Rotterdam, Netherlands

Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM

Gdansk, Poland

Gabinet Okulistyczny Prof. Edward Wylegala

Katowice, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki

Warsaw, Poland

Military Institute of Medecine - National Institute of Research

Warsaw, Poland

Hospital Universitario Virgen de las Nieves

Granada, Spain

Virgen de las Nieves University Hospital

Granada, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Ramón y Caja

Madrid, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Miguel Servet University Hospital

Zaragoza, Spain

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

Leeds, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital

London, United Kingdom

FaceRestoration Ltd

London, United Kingdom

Opal Clinic London Ltd

London, United Kingdom

South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary

Sunderland, United Kingdom

South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary

Sunderland, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06514612