A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children

Обзор

Efficacy and Safety Study of QLM3004 in Myopic Children

Подробное описание

The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period.

Stage 1:To evaluate the safety and efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period.

Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of QLM3004.

Вмешательства

• Препарат QLM3004 Concentration 1
  Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
• Препарат QLM3004 Concentration 2
  Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
• Препарат QLM3004 Concentration 3
  High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
• Другое Placebo
  Vehicle

Первичные конечные точки

• Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. [Срок оценки: 96 week]

Критерии участия

Критерии включения

• Age 6 to 12 years
• Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured by cycloplegic autorefraction.
• Astigmatism ≤1.50 D in both eyes.
• Anisometropia ≤1.50 D SE.
• Informed consent signed by the subjects and/or their legal representatives

Критерии исключения

• Suffering from serious systemic diseases
• Any eye disease that affect vision or refractive error
• Current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes
• Acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation
• Best corrected distance visual acuity in both eyes<4.9
• Abnormal intra-ocular pressure (>21 mmHg or difference between two eyes >5mmHg)
• Current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
• Systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry)
• Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium
• Participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment
• Participation of the drug clinical trial within three month and the device clinical trial within one month
• Anticipated long-term use of ocular or systemic oral corticosteroids during the study period
• Any other condition not suitable for the study per investigator's judgement

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 · 1 центр

• The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT06151587 · QLM3004-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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