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A Study in Chinese Patients With Acquired Blepharoptosis

13 de mayo de 2026 actualizado por: Santen Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Parallel Group Phase III Study to Evaluate the Efficacy and Safety of STN1013800 Ophthalmic Solution in Chinese Patients With Acquired Blepharoptosis

This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis.

At present, there are no medicines for the treatment of acquired blepharoptosis in China.

Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed.

For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

180

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Santen Pharmaceuticals Co., Ltd Clinical Operations
  • Número de teléfono: +81-6-4802-9341
  • Correo electrónico: clinical@santen.co.jp

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Reclutamiento
        • Beijing Luhe Hospital, Capital Medical University
        • Contacto:
          • Dr Zhang
    • Anhui
      • Hefei, Anhui, Porcelana
        • Reclutamiento
        • The Second Hospital of Anhui Medical University
        • Contacto:
          • Dr Tao
      • Hefei, Anhui, Porcelana
        • Reclutamiento
        • Anhui Provincial Hospital
        • Contacto:
          • Dr Wen
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana
        • Reclutamiento
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contacto:
          • Dr Tao
    • Guangdong
      • Shantou, Guangdong, Porcelana
        • Reclutamiento
        • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
        • Contacto:
          • Dr Zhang
    • Guizhou
      • Guiyang, Guizhou, Porcelana
        • Reclutamiento
        • Affiliated Hospital of Guizhou Medical University
        • Contacto:
          • Dr Gu
    • He'nan
      • Zhengzhou, He'nan, Porcelana
        • Reclutamiento
        • The First Affiliated Hospital of Zhengzhou University
        • Contacto:
          • Dr Li
    • Helongjiang
      • Ha’erbin, Helongjiang, Porcelana
        • Reclutamiento
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contacto:
          • Dr Sun
    • Hubei
      • Wuhan, Hubei, Porcelana
        • Reclutamiento
        • Wuhan Aier Eye Hospital
        • Contacto:
          • Dr Wang
      • Xiangyang, Hubei, Porcelana
        • Reclutamiento
        • Xiangyang Central Hospital
        • Contacto:
          • Dr Mao
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana
        • Reclutamiento
        • Nanjing First Hospital
        • Contacto:
          • Dr Li
    • Jilin
      • Changchun, Jilin, Porcelana
        • Reclutamiento
        • The Second Norman Bethune Hospital of Jilin University
        • Contacto:
          • Dr Su
    • Liaoning
      • Dali, Liaoning, Porcelana
        • Reclutamiento
        • Dalian No.3 Peple's Hospital
        • Contacto:
          • Dr Zhang
      • Shenyang, Liaoning, Porcelana
        • Reclutamiento
        • The 4th People's Hospital of Shenyang
        • Contacto:
          • Dr Xu
    • Ningbo
      • Zhenjiang, Ningbo, Porcelana
        • Reclutamiento
        • The affiliated People's Hospital of Ningbo
        • Contacto:
          • Dr Zhang
    • Shandong
      • Jinan, Shandong, Porcelana
        • Reclutamiento
        • Shandong Eye Hospital
        • Contacto:
          • Dr Shi
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana
        • Reclutamiento
        • Eye & ENT Hospital of Fudan University
        • Contacto:
          • Dr Sun
    • Shanxi
      • Taiyuan, Shanxi, Porcelana
        • Reclutamiento
        • Shanxi Eye Hospital
        • Contacto:
          • Dr Ren
    • Sichuan
      • Panzhihua, Sichuan, Porcelana
        • Reclutamiento
        • Panzhihua Hospital of Integrated Chinese and Western Medicine
        • Contacto:
          • Dr Zhou
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Porcelana
        • Reclutamiento
        • Tianjin Eye Hospital
        • Contacto:
          • Dr Zhao
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana
        • Reclutamiento
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contacto:
          • Dr Cui
      • Hangzhou, Zhejiang, Porcelana
        • Reclutamiento
        • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
        • Contacto:
          • Dr Wang
      • Wenzhou, Zhejiang, Porcelana
        • Reclutamiento
        • Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
        • Contacto:
          • Dr Wang

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • At least one eye diagnosed with acquired blepharoptosis and presence of all the following criteria at screening:

    • Loss of reliable Leicester Peripheral Field Test (LPFT) of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects had to see at least 9 total points in the top 4 rows (LPFT Total Score).
    • This criterion had to be met in both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments.
    • There had to be ≤4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score.
    • The Marginal Reflex Distance-1 (MRD-1), the distance from the pupil center to the margin of upper lid, ≤ 2 mm (no visible pupil center defaults to 0) in the same eye
    • Visual acuity is 0.25 decimals (i.e., Snellen 20/80) or better according to standard logarithmic visual acuity chart in the same eye

  • Presence of all the following criteria at baseline:

    • Loss of reliable LPFT of ≥8 points in the top 2 rows (LPFT Eligibility Score) in the same eye; subjects had to see at least 9 total points in the top 4 rows (LPFT Total Score).
    • This criterion had to be met in the Visit 2 Hour 0 (V2H0) LPFT assessment
    • There had to be ≤4 points of variance between the V1H6 and the V2H0 LPFT Eligibility Score;
    • The MRD-1, the distance from the pupil center to the margin of upper lid, ≤ 2 mm (no visible pupil center defaults to 0) in the same eye
    • Visual acuity is 0.25 decimals (i.e., Snellen 20/80) or better according to standard logarithmic visual acuity chart in the same eye
  • Female subjects are 1-year postmenopausal, surgically sterilized, or females of childbearing potential (females who had started their menstrual cycles) with a negative urine pregnancy test at screening. Females of childbearing potential had to use an acceptable form of contraception throughout the study.

Exclusion Criteria: In the study eye

  • Dermatochalasis that extended less than 3 mm above the upper eyelid margin.
  • Pseudoptosis (upper eyelid dermatochalasis that overhung the upper eyelid margin).
  • In either eye: Congenital ptosis; Horner syndrome; Marcus Gunn jaw-winking syndrome; Myasthenia gravis.
  • Mechanical ptosis, including ptosis due to orbital or lid tumour, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
  • Previous ptosis surgery (previous blepharoplasty [only] was allowed provided the surgery took place > 3 months prior to screening).
  • Lid position affected by lid or conjunctival scarring; Visual field loss from any cause other than ptosis; History of herpes keratitis.
  • History of closed/narrow angle glaucoma (unless patent peripheral iridotomy had been performed > 3 months prior to screening).
  • Periocular neurotoxin (e.g., Botox®, Dysport®) injections within 3 months prior to screening and during the study.
  • Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 7 days prior to screening and during the study.
  • Use of topical ophthalmic medications including but not limited to anti-allergy [e.g., antihistamines like Emadine®, Patanol®], dry eye [e.g., Diquas®, Beifushu®; except artificial tears like Hyaluronate], antimicrobial drugs [e.g., antibiotics and antivirals like Cravit®,Tobrex®, Aciclovir], and anti-inflammatory drugs
  • Current punctal plugs or placement of punctal plugs during the study.
  • Current use of over-the-counter (OTC) vasoconstrictor/decongestant eye medication or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products at any time during the study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: STN1013800 ophthalmic solution
0.1% STN1013800 ophthalmic solution administered once daily
Droga: STN1013800 ophthalmic solution
Investigational Product: 0.1% STN1013800 ophthalmic solution
Comparador de placebos: STN1013800 ophthalmic solution Liquid Base, without STN1013800
STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily
Droga: STN1013800 ophthalmic solution Liquid Base, without STN1013800
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Periodo de tiempo: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Mean change from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group in number of points seen in the top 4 rows on the Leicester Peripheral Field Test (LPFT test) at 2 time points
Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Periodo de tiempo: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Mean change of MRD-1 from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at 2 time points
Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Periodo de tiempo: Day 1 at Minute 5, Minute 15, Hour 2; Day 14 at Minute 5, Minute 15, Hour 6; Day 42 at Minute 5, Minute 15
Mean change of MRD-1 from Baseline (Day1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at other timepoints
Day 1 at Minute 5, Minute 15, Hour 2; Day 14 at Minute 5, Minute 15, Hour 6; Day 42 at Minute 5, Minute 15

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Santen Pharmaceutical Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de octubre de 2024

Finalización primaria (Estimado)

1 de junio de 2026

Finalización del estudio (Estimado)

1 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2024

Publicado por primera vez (Actual)

12 de noviembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 101380002CN

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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