Nailfold Capillary Blood Flow With Latanoprost Bunod

Phase 4

Completed

Conditions: Glaucoma, Open-Angle

Interventions: Drug: Latanoprost 0.005%
Drug: Latanoprost bunod 0.024%
Drug: Normal saline 0.9%
Diagnostic Test: Nailfold capillaroscopy

Registration Number: NCT03949244

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

Inclusion Criteria

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 ≤ 0.2.
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.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Latanoprost 0.005%	Latanoprost 0.005%	Latanoprost 0.005% drops to the nailfold.
Latanoprost bunod 0.024%	Nailfold capillaroscopy	Latanoprost bunod 0.024% drops to the nailfold.
Latanoprost bunod 0.024%	Latanoprost bunod 0.024%	Latanoprost bunod 0.024% drops to the nailfold.
Latanoprost 0.005%	Nailfold capillaroscopy	Latanoprost 0.005% drops to the nailfold.
Normal saline 0.9%	Nailfold capillaroscopy	Normal saline 0.9% to the nailfold.
Normal saline 0.9%	Normal saline 0.9%	Normal saline 0.9% to the nailfold.

Primary Outcome Measures

Name	Time	Method
NFC Blood Flow at Baseline and 15 Minutes	baseline and 15 minutes	NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.

Secondary Outcome Measures