Clinical trial NCT06683651: A Study in Chinese Patients With Acquired Blepharoptosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Blepharoptosis
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


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.

Primary outcomes:
measure: Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
timeFrame: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Secondary outcomes:
measure: Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
timeFrame: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
measure: Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
timeFrame: 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
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Ha'erbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Helongjiang
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Aier Eye Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changchun
country: China
facility: The second norman bethune hospital of Jilin University
state: Jilin
city: Dali
country: China
facility: Dalian No.3 Peple's Hospital
state: Liaoning
city: Shenyang
country: China
facility: The 4TH People's Hospital of Shenyang
state: Liaoning
city: Jinan
country: China
facility: Shandong Eye Hospital
state: Shandong
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
state: Shanxi
city: Panzhihua
country: China
facility: Panzhihua Hospital of Integrated Chinese and Western Medicine
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
state: Zhejiang
Study officials:
References: