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NCT03949244 Clinical Trial

Nailfold Capillary Blood Flow With Latanoprost Bunod

Glaucoma, Open-Angle Clinical Trial

Official title:
Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03949244
Other study ID # GCO 18-2686
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 15, 2019
Est. completion date October 1, 2020

Study information
Verified date September 2021
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 47
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost 0.005%
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%
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%
Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
Diagnostic Test:
• Nailfold capillaroscopy
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.

Locations
Country Name City State
United States New York Eye and Ear Infirmary of Mount Sinai New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary NFC Blood Flow at Baseline and 15 Minutes NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand. baseline and 15 minutes
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