A Study in Chinese Patients With Acquired Blepharoptosis

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.

Study Overview

• Status: Recruiting
• Conditions: Blepharoptosis
• Intervention / Treatment: Drug: STN1013800 ophthalmic solution; Drug: STN1013800 ophthalmic solution Liquid Base, without STN1013800

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Santen Pharmaceuticals Co., Ltd Clinical Operations; Phone Number: +81-6-4802-9341; Email: clinical@santen.co.jp

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STN1013800 ophthalmic solution; 0.1% STN1013800 ophthalmic solution administered once daily	Drug: STN1013800 ophthalmic solution; Investigational Product: 0.1% STN1013800 ophthalmic solution
Placebo Comparator: STN1013800 ophthalmic solution Liquid Base, without STN1013800; STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily	Drug: STN1013800 ophthalmic solution Liquid Base, without STN1013800; Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group	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	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

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis
• Other Study ID Numbers: 101380002CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No