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A Study in Chinese Patients With Acquired Blepharoptosis

13. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: STN1013800 ophthalmic solution
0.1% STN1013800 ophthalmic solution administered once daily
Legemiddel: 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
Legemiddel: STN1013800 ophthalmic solution Liquid Base, without STN1013800
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Santen Pharmaceutical Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. oktober 2024

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. juni 2026

Datoer for studieregistrering

Først innsendt

8. november 2024

Først innsendt som oppfylte QC-kriteriene

8. november 2024

Først lagt ut (Faktiske)

12. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 101380002CN

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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