An open-label, single-arm, multicenter study to evaluate the safety and efficacy of TLG-001J in elementary and junior high school students with myopia (TLG-001J LT Study) (TLG-001J LT Study)

未提供0 个研究点目标入组 15 人开始时间: 2024年3月28日最近更新: 2024年7月9日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
入组人数: 15
主要终点: Evaluation of adverse events

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Prevention Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 6age old over 至 15age old under（—）
性别: All

入选标准

•Japanese male and female elementary and junior high school students with myopia aged 6~15 years at the time of obtaining consent
•Patients with anisometropia within 1.50D
•Patients with astigmatism within +/-1.50D in both eyes
•Patients with corrected visual acuity of 1.2 or more in both eyes
•Patients who can perform the procedure under control paralysis
•Patients who can undergo a clinical examination according to the study protocol
•Patients who have given written consent to participate in the study by themselves and their substitute consents

排除标准

•Patients with a history of ophthalmic surgery, including refractive surgery
•Patients taking methoxalen (Oxolaren Tablets 10 mg)
•Patients with a history or suspicion of photosensitivity
•Patients with a history of epilepsy
•Patients with binocular visual dysfunction
•Patients with amblyopia or overt strabismus
•Patients with a difference in objective refraction (SE) of 1.50D or more in each eye under accommodative and nonaccommodative paralysis
•Patients with guttate cornea or corneal endothelial cell density less than 2,000 cells/mm^2
•Patients with eye-related or systemic diseases that may affect visual acuity or refractive index other than myopia
•Patients who take or have taken drugs that affect neurotransmitters or growth
•Patients who have taken or will take supplements containing crocetin (However, if more than one month has passed since the end of intake of supplements containing crocetin, the product may be included.)
•Patients who have received or have received atropine treatment, orthokeratology, multifocal (Includes progressive, double focus) glasses or contact lenses.
•Patients with a history of allergy to fluorescein, oxybuprocaine hydrochloride (such as benoxilophthalmic solution 0.4%), cyclopentolate hydrochloride (cypledin 1% ophthalmic solution), or benzalkonium
•Patients likely to require contact lenses (Monofocal, multifocal, orthokeratology, etc.) or multifocal glasses during the study period
•Patients unable to wear study equipment continuously during the study period, including during extended vacation periods such as summer vacation
•Patients who have used TLG-001 during exploratory and confirmatory clinical trials
•Other patients who were deemed unsuitable for inclusion in this study by the responsible (shared) physician

结局指标

主要结局

Evaluation of adverse events

时间窗: 24 months

Evaluation of adverse events up to 24 months in patients who discontinued treatment due to safety after starting use of TLG-001J

次要结局

Visual acuity test using a Landolt ring(24 months (96 weeks))
Morphological, structural, and quantitative evaluation of the retina using OCT(24 months (96 weeks))
Corneal endothelial cell density measurement using a corneal endothelial cell counter(24 months (96 weeks))
Skin disorder around the eyes due to the physician's opinion(24 months (96 weeks))
Observation of anterior segment and intermediate translucent body by slit-lamp(24 months (96 weeks))
Monocular or binocular indirect ophthalmoscopy(24 months (96 weeks))
Changes in axial length(1 month (Week 4), 3 months (Week 12), 6 months (Week 24), 12 months (Week 48), 18 months (Week 72), and 24 months (Week 96))
Changes in choroidal thickness(12 months (Week 48) and 24 months (Week 96))

研究者

发起方

未提供

相似试验

进行中（未招募）

1 期

Treatment of advanced or metastatic triple negative breast cancer with tumor infiltrating lymphocytes (TILs).advanced or metastasic triple-negative breast cancerMedDRA version: 23.0Level: LLTClassification code: 10084066Term: Triple negative breast cancer metastatic Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864

CTIS2024-511915-21-01Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer20

已完成

不适用

TO-210 Phase 1 Study

jRCT2071230128Torii Pharmaceutical Co.,Ltd34

招募中

不适用

NOL study (NOL study)

jRCTs072240066110

招募中

不适用

LOGIK2401(NECTAR Study)

jRCTs07124005430

进行中（未招募）

1 期

Bioequivalence of Betis®10 mg Film-Coated Tablets versus Clozan 10 mg tablets in Healthy Subjectso medical condition.

CTIS2023-504901-34-00Synthon Chile LTDA.30