Nailfold Capillary Blood Flow With Latanoprost Bunod

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Latanoprost 0.005%; Diagnostic test: Nailfold capillaroscopy; Drug: Latanoprost bunod 0.024%; Drug: Normal saline 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary of Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Latanoprost 0.005%; Latanoprost 0.005% drops to the nailfold.	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.; Other Names: Xalatan; 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.; Other Names: NFC
Experimental: Latanoprost bunod 0.024%; Latanoprost bunod 0.024% drops to the nailfold.	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.; Other Names: NFC; Drug: 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.; Other Names: Vyzulta; LTB
Placebo Comparator: Normal saline 0.9%; Normal saline 0.9% to the nailfold.	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.; Other Names: NFC; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Robert Ritch, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: May 12, 2019
• First Submitted That Met QC Criteria: May 12, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Latanoprost; Nailfold capillary imaging; Latanoprost bunod
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: GCO 18-2686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results of the study will be shared as publications in peer-reviewed journals and at scientific meetings. All data to be shared will be de-identified. Study subjects may request to learn the results of the study, which will be provided orally by the study staff, or they will be referred to any publications.
• IPD Sharing Time Frame: Results will be shared upon completion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No