JPRN-jRCT2051210054进行中（未招募）2 期
A randomized, placebo-controlled, double-masked, multicenter, dose-ranging study to evaluate the safety, and efficacy of UNR844 in subjects with presbyopia
Yamada Hiroyuki0 个研究点目标入组 45 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- >= 45age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •Phakic male or female participants aged 45 to 55 years, inclusive, at the Screening visit.
- •- Monocular and binocular distance-corrected near visual acuity at 40 cm distance worse than 0.3 logMAR at the Screening and Baseline visits.
- •- Binocular distance-corrected near visual acuity at baseline must not be different by more than 0.1 logMAR from the corresponding assessment at the Screening visit.
- •- Need a minimum near addition prescription of +1.00 D or more to achieve binocular DCNVA of at least 0.0 logMAR at 40 cm distance, as assessed by the Investigator, at the Screening visit.
排除标准
- •- Best-corrected distance visual acuity worse than 0.0 logMAR at 4 m distance in either eye at the Screening visit.
- •- Spherical equivalent greater than +4.0 D or less than -4.0 D, based on manifest refraction, in either eye at the Screening visit.
- •- Astigmatism of greater than 1.25 D, based on manifest refraction, in either eye at the Screening visit.
- •- Difference in manifest refraction spherical equivalent of greater than 0.75 D between eyes at the Screening visit.
- •- Any ocular or systemic condition that, in the opinion of the Investigator, would jeopardize subject safety, has an impact on visual acuity, affects study assessments or validity of study results
研究者
相似试验
进行中（未招募）
不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.Ensayo multicéntrico, con doble enmascaramiento, controlado con placebo y aleatorizado de la inyección intravítrea de microplasmina para el tratamiento no quirúrgico de la adherencia vitreomacular focal.Focal Vitreomacular AdhesionAdherencia Vitreomacular FocalMedDRA version: 9.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeEUCTR2008-004393-40-ESThromboGenics NV320
进行中（未招募）
不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.Focal Vitreomacular AdhesionMedDRA version: 9.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeEUCTR2008-004393-40-BEThromboGenics NV320
进行中（未招募）
不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.EUCTR2008-004393-40-DEThromboGenics NV320
进行中（未招募）
不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.EUCTR2008-004393-40-GBThromboGenics NV320
进行中（未招募）
不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.Focal Vitreomacular AdhesionMedDRA version: 9.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeEUCTR2008-004393-40-CZThromboGenics NV320