Nailfold Capillary Blood Flow With Latanoprost Bunod
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Latanoprost 0.005%; Latanoprost bunod 0.024%; Normal saline 0.9%; Nailfold capillaroscopy
Intervention type(s): Drug; Drug; Drug; Diagnostic Test
Intervention description(s): Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.; Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.; Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.; An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
Other intervention name(s): Xalatan; Vyzulta; LTB; NFC
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nailfold capillary imaging; Latanoprost bunod; Latanoprost