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New treatment option for Blepharoptosis
Official title A Study in Chinese Patients With Acquired Blepharoptosis
ClinicalTrials.gov ID: NCT06683651
What this study is testing
What is STN1013800 ophthalmic solution?
STN1013800 ophthalmic solution is an investigational medicine, given as an once-daily, being studied as a potential treatment for blepharoptosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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); people had to see at least 9 total...
- 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)...
You likely can't join if
- 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).
See the full eligibility 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); people 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; people 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 people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Shantou, Guangdong, China
- Guiyang, Guizhou, China
- Zhengzhou, He'nan, China
- Ha’erbin, Helongjiang, China
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Dali, Liaoning, China
- Shenyang, Liaoning, China
- Zhenjiang, Ningbo, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Panzhihua, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Shantou, Guangdong, China; Guiyang, Guizhou, China; Zhengzhou, He'nan, China; Ha’erbin, Helongjiang, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.