Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study in Chinese Patients With Acquired Blepharoptosis

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Santen Pharmaceuticals Co., Ltd Clinical Operations
  • Telefonnummer: +81-6-4802-9341
  • E-mail: clinical@santen.co.jp

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: STN1013800 ophthalmic solution
0.1% STN1013800 ophthalmic solution administered once daily
Medicin: STN1013800 ophthalmic solution
Investigational Product: 0.1% STN1013800 ophthalmic solution
Placebo komparator: STN1013800 ophthalmic solution Liquid Base, without STN1013800
STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily
Medicin: STN1013800 ophthalmic solution Liquid Base, without STN1013800
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Santen Pharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. oktober 2024

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

8. november 2024

Først indsendt, der opfyldte QC-kriterier

8. november 2024

Først opslået (Faktiske)

12. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 101380002CN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner