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临床试验/NCT03949244
NCT03949244已完成4 期

Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
47
试验地点
1
主要终点
NFC Blood Flow at Baseline and 15 Minutes

研究概览

简要总结

The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finger is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.

详细描述

In this study, the study team investigates the effect of topically-applied latanoprostene bunod (LTB) on the blood flow at the nailfold of the 4th finger in patients with primary open angle glaucoma. LTB is a new anti-glaucoma eye drop which received FDA clearance in early November 2017. It has two components: the prostaglandin analog (PGA) which decreases intraocular pressure (IOP) by enhancing the drainage of the aqueous (the fluid in the front part of the eye) from the eye, and the nitric oxide (NO) moiety which naturally dilates arteries in the body. The capillaries at the nailfold are comparable to those of the optic nerve head, which makes them a reasonable surrogate for evaluation of the effect of LTB on the blood flow. Therefore, this study may provide indirect evidence for the beneficial effect of LTB on blood flow to optic nerve which can potentially save the optic nerve from glaucomatous damage. Primary open angle glaucoma is a progressive condition and is the most common cause of irreversible blindness worldwide. Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease.

In addition to LTB, the study team will use latanoprost (L), an-FDA approved PGA anti-glaucoma eye drop and normal saline (NS: the physiologic solution composed of 0.9% salt and water), as controls to make sure the effects of LPB on nail fold capillary blood flow is not due to its PGA (as L is) or due to the placebo effect (as NS is).

This study may also serve as background information for the development of new anti-glaucoma medications which can be injected into the eye to facilitate blood flow to the optic nerve.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Patients will have baseline NFC blood flow measurements after application of cedar oil. Then the study team will use NF application of either normal saline, latanoprost 0.005% or LTB 0.024% in random sequence. The patient and imager will know which study article is applied. NFC blood flow will be remeasured after 15 minutes. Preliminary data on controls suggests that 15 minutes is sufficient time to see a change in blood flow. NF article application will occur on a specially designed well applied to the 4th digit of the non-dominant hand. Two masked observers will evaluate NFC blood flow.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40 years old to 80 years old
  • All participants will have open angles and no signs of secondary glaucoma such as exfoliation syndrome
  • Untreated intraocular pressure (IOP) may be ≤ 21mmHg or ≥ 21mmHg in both eyes
  • The cup-to-disc ratio (CDR) ≥ 0.6 in both eyes and CDR asymmetry ≤ 0.
  • POAG patients will have reliable Humphrey Visual Field (HVF) loss consistent with optic nerve damage
  • POAG patients can have any stage of POAG and be on any form of treatment for their disease.
  • Willingness to sign informed consent and comply with study procedures.

排除标准

  • History of non-POAG forms of glaucoma
  • Pregnancy
  • Inability to give informed consent

研究组 & 干预措施

Latanoprost 0.005%

Active Comparator

Latanoprost 0.005% drops to the nailfold.

干预措施: Latanoprost 0.005% (Drug)

Latanoprost 0.005%

Active Comparator

Latanoprost 0.005% drops to the nailfold.

干预措施: Nailfold capillaroscopy (Diagnostic Test)

Latanoprost bunod 0.024%

Experimental

Latanoprost bunod 0.024% drops to the nailfold.

干预措施: Latanoprost bunod 0.024% (Drug)

Latanoprost bunod 0.024%

Experimental

Latanoprost bunod 0.024% drops to the nailfold.

干预措施: Nailfold capillaroscopy (Diagnostic Test)

Normal saline 0.9%

Placebo Comparator

Normal saline 0.9% to the nailfold.

干预措施: Normal saline 0.9% (Drug)

Normal saline 0.9%

Placebo Comparator

Normal saline 0.9% to the nailfold.

干预措施: Nailfold capillaroscopy (Diagnostic Test)

结局指标

主要结局

NFC Blood Flow at Baseline and 15 Minutes

时间窗: baseline and 15 minutes

NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Tsai

Professor and System Chair of Ophthalmology

Icahn School of Medicine at Mount Sinai

研究点 (1)

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