临床试验/NCT01668524

NCT01668524已完成2 期

A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

Altheos, Inc.1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2012年8月最近更新: 2012年9月7日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Altheos, Inc.
入组人数: 12
试验地点: 1
主要终点: Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or greater
•Diagnosis of open angle glaucoma or ocular hypertension in both eyes
•Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) in each eye (equivalent to 20/200)
•Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study

排除标准

•Ophthalmic (in either eye):
•Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Refractive surgery in study eye
•Cataract surgery and or other intraocular surgery within one month prior to Screening in either eye
•History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis
•Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented
•Contact lens wear during the duration of the study
•Clinically significant ocular disease (e.g., diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study

研究组 & 干预措施

Single Arm: ATS907

Experimental

Single-cohort, dose-escalation

干预措施: ATS907 (Drug)

结局指标

主要结局

Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

发起方

Altheos, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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