A Study in Chinese Patients With Acquired Blepharoptosis

Официальное название

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

Обзор

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.

Вмешательства

• Препарат STN1013800 ophthalmic solution
  Investigational Product: 0.1% STN1013800 ophthalmic solution
• Препарат STN1013800 ophthalmic solution Liquid Base, without STN1013800
  Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Первичные конечные точки

• Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group [Срок оценки: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)]

Вторичные конечные точки (2)

• Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 23 центра

• Anhui Provincial Hospital — Хэфэй
• The Second Hospital of Anhui Medical University — Хэфэй
• Beijing Chaoyang Hospital, Capital Medical University — Пекин
• Joint Shantou International Eye Center of Shantou University and the Chinese University of — Shantou
• Affiliated Hospital of Guizhou Medical University — Guiyang
• The first affiliated hospital of Zhengzhou University — Чжэнчжоу
• The 2nd Affiliated Hospital of Harbin Medical University — Ha’erbin
• Wuhan Aier Eye Hospital — Ухань
• … и ещё 15 центров

Идентификаторы

NCT: NCT06683651 · 101380002CN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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