Actively Recruiting
A Study in Chinese Patients With Acquired Blepharoptosis
Led by Santen Pharmaceutical Co., Ltd. · Updated on 2024-11-12
180
Participants Needed
21
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study in Chinese Patients With Acquired Blepharoptosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one eye diagnosed with acquired blepharoptosis
- Loss of reliable Leicester Peripheral Field Test (LPFT) of �3e= 8 points in the top 2 rows at screening and baseline
- Subjects must see at least 9 total points in the top 4 rows on LPFT
- No more than 4 points variance between LPFT assessments at specified visits
- Marginal Reflex Distance-1 (MRD-1) �3c= 2 mm in the same eye
- Visual acuity of 0.25 decimals (Snellen 20/80) or better in the same eye
- Female participants must be 1-year postmenopausal, surgically sterilized, or using effective contraception with a negative pregnancy test
You will not qualify if you...
- Dermatochalasis extending less than 3 mm above the upper eyelid margin
- Pseudoptosis caused by upper eyelid dermatochalasis
- Congenital ptosis, Horner syndrome, Marcus Gunn jaw-winking syndrome, or Myasthenia gravis in either eye
- Mechanical ptosis due to tumors, scarring, or enophthalmos
- Previous ptosis surgery (except blepharoplasty over 3 months prior)
- Lid position affected by scarring or visual field loss from causes other than ptosis
- History of herpes keratitis or closed/narrow angle glaucoma without prior iridotomy
- Periocular neurotoxin injections within 3 months prior or during the study
- Use of bimatoprost on eyelashes within 7 days prior 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/decongestant eye medications or alpha-adrenergic agonists during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Not Yet Recruiting
5
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
6
The first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan, China
Actively Recruiting
7
The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang, China
Not Yet Recruiting
8
Wuhan Aier Eye Hospital
Wuhan, Hubei, China
Not Yet Recruiting
9
Xiangyang Central Hospital
Xiangyang, Hubei, China
Not Yet Recruiting
10
The second norman bethune hospital of Jilin University
Changchun, Jilin, China
Not Yet Recruiting
11
Dalian No.3 Peple's Hospital
Dali, Liaoning, China
Not Yet Recruiting
12
The 4TH People's Hospital of Shenyang
Shenyang, Liaoning, China
Not Yet Recruiting
13
Shandong Eye Hospital
Jinan, Shandong, China
Actively Recruiting
14
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
15
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
16
Panzhihua Hospital of Integrated Chinese and Western Medicine
Panzhihua, Sichuan, China
Actively Recruiting
17
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
18
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
19
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
20
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
21
Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
S
Santen Pharmaceuticals Co., Ltd Clinical Operations
CONTACT
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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