Evaluating a new eye drop treatment for droopy eyelids in Chinese patients
Official title: 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
Run by Santen Pharmaceutical Co., Ltd. · NCT06683651 · Data updated 2026-11-12
This study is testing a new eye drop treatment for droopy eyelids to see if it helps Chinese patients who currently have no medication options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Santen Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 23 sites (Hefei, Anhui and 22 other locations) |
| Status | Recruiting |
| Started | October 22, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06683651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Chinese patients diagnosed with acquired blepharoptosis who meet specific visual acuity and field test criteria.
✕Probably not a fit
Patients with other forms of eyelid drooping or those who do not meet the eligibility criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase III study aims to assess the efficacy and safety of STN1013800 ophthalmic solution in treating acquired blepharoptosis in Chinese patients. Participants will receive either the active treatment or a placebo over a 42-day period, with eligibility determined through specific visual field tests and measurements. The study is designed to fill a significant gap in treatment options for this condition in China, where no medications currently exist.
Why it matters
Potential benefit: If successful, this treatment could provide a much-needed therapeutic option for patients suffering from acquired blepharoptosis.
How similar studies have gone: While this approach is novel in the context of acquired blepharoptosis treatment in China, similar studies in other regions have shown promise with comparable interventions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Anhui Provincial Hospital
Hefei, Anhui, China Recruiting -
The Second Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting -
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China Recruiting -
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China Recruiting -
The first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan, China Recruiting
Show 17 more locations
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The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang, China Recruiting -
Wuhan Aier Eye Hospital
Wuhan, Hubei, China Recruiting -
Xiangyang Central Hospital
Xiangyang, Hubei, China Recruiting -
Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting -
The second norman bethune hospital of Jilin University
Changchun, Jilin, China Recruiting -
Dalian No.3 Peple's Hospital
Dali, Liaoning, China Recruiting -
The 4TH People's Hospital of Shenyang
Shenyang, Liaoning, China Recruiting -
The affiliated People's Hospital of Ningbo
Zhenjiang, Ningbo, China Recruiting -
Shandong Eye Hospital
Jinan, Shandong, China Recruiting -
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Shanxi Eye Hospital
Taiyuan, Shanxi, China Recruiting -
Panzhihua Hospital of Integrated Chinese and Western Medicine
Panzhihua, Sichuan, China Recruiting -
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China Recruiting -
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting -
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting -
Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
Wenzhou, Zhejiang, China Recruiting -
Beijing Luhe Hospital, Capital Medical University
Beijing, China Recruiting
Study contacts
- Study coordinator: Santen Pharmaceuticals Co., Ltd Clinical Operations
- Email: clinical@santen.co.jp
- Phone: +81-6-4802-9341
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blepharoptosis After Repeated Anti-VEGF Injections in One Eye
This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.
-
Device for managing eyelid drooping
This study tests a new device that helps lift drooping eyelids for people with blepharoptosis to see if it works better than surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.