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A Study to Evaluate the Efficacy and Safety of STN1013800 Ophthalmic Solution Compared to Placebo in Chinese Patients With Acquired Blepharoptosis
Led by Santen Pharmaceutical Co., Ltd. · Updated on 2026-05-15
180
Participants Needed
23
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a new drug called STN1013800 ophthalmic solution for treating acquired blepharoptosis in Chinese patients. This condition involves drooping of the upper eyelid, and currently, there are no approved medicines for this in China. This is a Phase III randomized, double-masked, placebo-controlled study designed to compare STN1013800 with a placebo solution. Participants will receive either 0.1% STN1013800 ophthalmic solution or a placebo once daily for 42 days, based on prior clinical trial results. The study includes a screening period lasting 3 to 7 days to confirm eligibility. The interventions involve applying the assigned eye drops daily, with the study treatment and placebo groups monitored in parallel. During the study, participants will undergo multiple assessments including margin reflex distance-1 (MRD-1) measurements and Leicester Peripheral Field Test (LPFT) scores at several time points (Day 1 Hour 6, Day 14 Hour 2, and Day 42). Researchers will track changes from baseline in eyelid position and visual function to evaluate treatment effects. Safety and adherence will also be monitored throughout the 42-day treatment period.
CONDITIONS
Brief Title
A Study in Chinese Patients With Acquired Blepharoptosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of acquired blepharoptosis in at least one eye
- Loss of reliable Leicester Peripheral Field Test (LPFT) of 8 or more points in the top 2 rows and at least 9 points in the top 4 rows
- LPFT criteria met at screening and baseline visits with minimal variance between assessments
- Marginal Reflex Distance-1 (MRD-1) of 2 mm or less in the affected eye
- Visual acuity of 0.25 decimals (Snellen 20/80) or better in the affected eye
- Female participants must be 1 year postmenopausal, surgically sterilized, or use effective contraception with a negative pregnancy test at screening
You will not qualify if you...
- Dermatochalasis extending less than 3 mm above the upper eyelid margin
- Pseudoptosis due to upper eyelid dermatochalasis
- Congenital ptosis, Horner syndrome, Marcus Gunn jaw-winking syndrome, or Myasthenia gravis in either eye
- Mechanical ptosis caused by tumors, scarring, or enophthalmos
- Previous ptosis surgery (except blepharoplasty performed more than 3 months before screening)
- Lid position affected by scarring or visual field loss from causes other than ptosis
- History of herpes keratitis or closed/narrow angle glaucoma unless treated
- Periocular neurotoxin injections within 3 months before screening or during the study
- Use of bimatoprost eyelash treatment within 7 days before screening or during the study
- Use of topical ophthalmic medications such as anti-allergy, dry eye, antimicrobial, or anti-inflammatory drugs
- Current or planned use of punctal plugs
- Use of over-the-counter vasoconstrictor or any alpha-adrenergic agonist eye medication during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 14 days
Participants receive once daily administration of either the investigational STN1013800 ophthalmic solution or placebo.
3 visits over 14 days including Day 1 Hour 6, Day 14 Hour 2, and additional assessments
Trial Site Locations
Total: 23 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
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2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
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3
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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4
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
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5
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
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6
The first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan, China
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7
The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang, China
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8
Wuhan Aier Eye Hospital
Wuhan, Hubei, China
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9
Xiangyang Central Hospital
Xiangyang, Hubei, China
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10
Nanjing First Hospital
Nanjing, Jiangsu, China
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11
The second norman bethune hospital of Jilin University
Changchun, Jilin, China
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12
Dalian No.3 Peple's Hospital
Dali, Liaoning, China
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13
The 4TH People's Hospital of Shenyang
Shenyang, Liaoning, China
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14
The affiliated People's Hospital of Ningbo
Zhenjiang, Ningbo, China
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15
Shandong Eye Hospital
Jinan, Shandong, China
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16
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China
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17
Shanxi Eye Hospital
Taiyuan, Shanxi, China
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18
Panzhihua Hospital of Integrated Chinese and Western Medicine
Panzhihua, Sichuan, China
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19
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
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20
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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21
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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22
Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
Wenzhou, Zhejiang, China
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23
Beijing Luhe Hospital, Capital Medical University
Beijing, China
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Research Team
S
Santen Pharmaceuticals Co., Ltd Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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