Evaluating a new eye drop treatment for droopy eyelids in Chinese patients

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 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
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Santen Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 21 sites (Hefei, Anhui and 20 other locations)
• Trial ID: NCT06683651 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients diagnosed with acquired blepharoptosis who meet specific visual acuity and field test criteria.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hefei, Anhui and 20 other locations

• 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 (Not_yet_recruiting)
• Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• The first affiliated hospital of Zhengzhou University — Zhengzhou, He'nan, China (Recruiting)
• The 2nd Affiliated Hospital of Harbin Medical University — Ha’erbin, Helongjiang, China (Not_yet_recruiting)
• Wuhan Aier Eye Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
• The second norman bethune hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Dalian No.3 Peple's Hospital — Dali, Liaoning, China (Not_yet_recruiting)
• The 4TH People's Hospital of Shenyang — Shenyang, Liaoning, China (Not_yet_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 (Not_yet_recruiting)
• Panzhihua Hospital of Integrated Chinese and Western Medicine — Panzhihua, Sichuan, China (Recruiting)
• Tianjin Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Santen Pharmaceuticals Co., Ltd Clinical Operations

Conditions Blepharoptosis