JPRN-jRCT2052210116进行中（未招募）3 期
A double-masked, multicenter, randomized, controlled trial of a daily disposable contact lens for myopia control (MIST) for myopia in Japanese children
Misumi Nobuko0 个研究点目标入组 60 人开始时间: 2021年11月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 8age old 至 <= 12age old（—）
- 性别
- All
入选标准
- •1. Subject who have read the informed assent form (IAF) for participation in the study, received an explanation of the IAF, understood the IAF, and can voluntarily consent to participate in the study.
- •2. The subject's legally acceptable representative has read the informed consent form (ICF), received and explanation of the ICF, understood the ICF, and can sign the ICF.
- •3. Subjects who understand the nature of the study and are willing to comply with the requirements, along with their legally acceptable representative.
- •4. Subjects who are willing to cooperate voluntarily with the study plan, such as following the follow-up schedule, along with their legally acceptable representative.
- •5. Subjects who can agree to be randomized.
- •6. Subjects who are willing to wear the study lens for 10 hours a day for at least 6 days a week during the study period. In addition, those who can agree to inform the investigator if this wearing schedule is suspended.
- •7. Subjects who have glasses with good vision available for use or will have glasses when they start to wear the study lenses.
- •8. Subjects who are generally in good health based on his/her and legally acceptable representative's knowledge.
- •9. Subjects who have a best-corrected visual acuity (BCVA) of +0.10 logMAR or more in each eye.
- •10. Subjects whose spherical equivalent power is -0.75 to -4.00D and cylindrical diopter is -0.75D or less and the difference in refractive power between right and left eyes is less than 1.00D in the cycloplegic refraction test using an autorefractometer at the initial visit.
排除标准
- •1. Subjects who appears to have poor hygiene habits.
- •2. Subjects who are participating or have participated in another clinical study (clinical trial) within 30 days prior to this study.
- •3. The subject's legally acceptable representative is an employee including investigator at the medical institution of this study.
- •4. Subjects who have previously worn HCL (RGP lenses), including orthokeratology lenses.
- •5. Subjects who are currently receiving or have previously received any myopia control treatment such as bifocal/progressive contact lenses or atropine.
- •6. Subjects who regularly use ocular medications, including artificial tears (prescription or over-the-counter drugs).
- •7. Subjects with a history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, infectious ocular inflammation, or other recurrent ocular inflammation.
- •8. Subjects diagnosed with strabismus.
- •9. Subjects with known ocular or systemic disease, such as, but not limited to, anterior uveitis, iritis, episcleritis, scleritis, glaucoma, Sjogren's syndrome, systemic lupus erythematosus, scleroderma or diabetes mellitus.
- •10. Subjects with keratoconus or an irregular cornea.
- •11. An investigator considers that it is not in the best interest of the subject to participate in the study.
研究者
相似试验
进行中（未招募）
2 期
A Multicenter, Randomized, Double-Masked Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) Implant in Patients with Non-Infectious Uveitis Affecting the Posterior Segment of the Eyeon-infectious Posterior UveitisNon-infectious Posterior UveitisEye - Diseases / disorders of the eyeACTRN12605000485639Bausch & Lomb (Rochester)40
招募中
2 期
A Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune DiseaseACTRN12623001230640Iolyx Australia Pty Ltd.110
进行中（未招募）
1 期
Study to evaluate the efficacy, safety, tolerability and the extent to which the study drug is distributed in the body of multiple doses of QR-110 in subjects with LCA10 compared to a sham procedure. The study will be double-masked, randomized and controlled which means that both patients and study staff will not know and cannot influence who receives which treatment (study drug of sham).EUCTR2018-003501-25-ITPROQR THERAPEUTICS N.V.30
进行中（未招募）
1 期
A Phase 2/3 study to evaluate efficacy, safety, and tolerability of QR-421a in subjects with with Early to Moderate Vision LossRetinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A GeneMedDRA version: 20.0Level: PTClassification code 10038914Term: Retinitis pigmentosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-002728-19-NOProQR Therapeutics IV B.V.120
进行中（未招募）
1 期
Study to evaluate the efficacy, safety, tolerability and the extent to which the study drug is distributed in the body of multiple doses of QR-110 in subjects with LCA10 compared to a sham procedure. The study will be double-masked, randomized and controlled which means that both patients and study staff will not know and cannot influence who receives which treatment (study drug of sham).eber’s Congenital Amaurosis (LCA) due to c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 GeneMedDRA version: 20.0Level: PTClassification code 10070667Term: Leber's congenital amaurosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-003501-25-NLProQR Therapeutics IV B.V.36