BlepharoptosisPhase 3NCT06683651
A Study in Chinese Patients With Acquired Blepharoptosis
A Phase 3 study testing STN1013800 ophthalmic solution and STN1013800 ophthalmic solution Liquid Base, without STN1013800 in people with Blepharoptosis, run by Santen Pharmaceutical Co., Ltd. at 23 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- STN1013800 ophthalmic solution and STN1013800 ophthalmic solution Liquid Base, without STN1013800
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 23 sitesChina
- Study dates
- 22 Oct 2024to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality
Dr Tao
- Recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing
Dr Zhang
- Recruiting
The second norman bethune hospital of Jilin University
Changchun, Jilin
Dr Su
- Recruiting
Dalian No.3 Peple's Hospital
Dali, Liaoning
Dr Zhang
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Dr Gu
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang
Dr Sun
- Recruiting
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang
Dr Wang
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Dr Cui
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Dr Wen
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Dr Tao
- Recruiting
Shandong Eye Hospital
Jinan, Shandong
Dr Shi
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu
Dr Li
- Recruiting
Panzhihua Hospital of Integrated Chinese and Western Medicine
Panzhihua, Sichuan
Dr Zhou
- Recruiting
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality
Dr Sun
- Recruiting
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong
Dr Zhang
- Recruiting
The 4TH People's Hospital of Shenyang
Shenyang, Liaoning
Dr Xu
- Recruiting
Shanxi Eye Hospital
Taiyuan, Shanxi
Dr Ren
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
Dr Zhao
- Recruiting
Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
Wenzhou, Zhejiang
Dr Wang
- Recruiting
Wuhan Aier Eye Hospital
Wuhan, Hubei
Dr Wang
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Dr Mao
- Recruiting
The first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan
Dr Li
- Recruiting
The affiliated People's Hospital of Ningbo
Zhenjiang, Ningbo
Dr Zhang
About this study
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
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
- Blepharoptosis
- Being tested
- STN1013800 ophthalmic solution, STN1013800 ophthalmic solution Liquid Base, without STN1013800
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN1013800 ophthalmic solutionDrug
Investigational Product: 0.1% STN1013800 ophthalmic solution
STN1013800 ophthalmic solution Liquid Base, without STN1013800Drug
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800
| Study group | Role | What they receive |
|---|---|---|
| STN1013800 ophthalmic solution | Experimental | 0.1% STN1013800 ophthalmic solution administered once daily Receives: Drug: STN1013800 ophthalmic solution |
| STN1013800 ophthalmic solution Liquid Base, without STN1013800 | Placebo comparator | STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily Receives: Drug: STN1013800 ophthalmic solution Liquid Base, without STN1013800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Secondary outcomes (2)
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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683651
- Sponsor's protocol ID
- 101380002CN
- Status last verified
- May 2026
- First submitted
- 8 Nov 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06683651
- Acronym / sponsor ID
- 101380002CN
- Conditions
- Blepharoptosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STN1013800 ophthalmic solution | Experimental | Drug: STN1013800 ophthalmic solution0.1% STN1013800 ophthalmic solution administered once daily |
| STN1013800 ophthalmic solution Liquid Base, without STN1013800 | Placebo comparator | Drug: STN1013800 ophthalmic solution Liquid Base, without STN1013800STN1013800 ophthalmic solution Liquid Base, without STN1013800 administered once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least one eye diagnosed with acquired blepharoptosis and presence of all the following criteria at screening:
- Presence of all the following criteria at baseline:
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN1013800 ophthalmic solutionInvestigational Product: 0.1% STN1013800 ophthalmic solution | Drug | STN1013800 ophthalmic solution |
| STN1013800 ophthalmic solution Liquid Base, without STN1013800Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800 | Drug | STN1013800 ophthalmic solution Liquid Base, without STN1013800 |
Primary outcome
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Time frame: 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
2 secondary outcomes
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STN1013800 ophthalmic solution and STN1013800 ophthalmic solution Liquid Base, without STN1013800 in people with Blepharoptosis, run by Santen Pharmaceutical Co., Ltd. at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santen Pharmaceuticals Co., Ltd Clinical Operations (+81-6-4802-9341, clinical@santen.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group (time frame: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.