Nailfold Capillary Blood Flow With Latanoprost Bunod

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ClinicalTrials.gov Identifier: NCT03949244

Recruitment Status : Not yet recruiting

First Posted : May 14, 2019

Last Update Posted : July 11, 2019

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Sponsor:

Information provided by (Responsible Party):

Robert Ritch, Icahn School of Medicine at Mount Sinai

Study Description

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 finder is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.

Condition or disease	Intervention/treatment	Phase
Glaucoma, Open-Angle	Drug: Latanoprost 0.005% Drug: Latanoprost bunod 0.024% Drug: Normal saline 0.9% Diagnostic Test: Nailfold capillaroscopy	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	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.
Primary Purpose:	Basic Science
Official Title:	Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
Estimated Study Start Date :	September 2019
Estimated Primary Completion Date :	April 30, 2020
Estimated Study Completion Date :	April 30, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: NFC
Experimental: Latanoprost bunod 0.024% Latanoprost bunod 0.024% drops to the nailfold.	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 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 Name: NFC
Placebo Comparator: Normal saline 0.9% Normal saline 0.9% to the nailfold.	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. 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 Name: NFC

Outcome Measures

Primary Outcome Measures :

Change in NFC blood flow [ Time Frame: baseline and 15 minutes ]
The change in NFC blood flow 15 minutes after NF application to the 4th digit of the nondominant hand at 15 minutes as compared to baseline.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949244

Contacts

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Contact: Emily Seo	212-979-4000 ext 5373	eseo@nyee.edu
Contact: Siddharth Bhargava	408-565-5436	SBhargava@nyee.edu

Locations

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United States, New York
New York Eye and Ear Infirmary of Mount Sinai	Not yet recruiting
New York, New York, United States, 10003
Contact: Maria Scolaro 212-979-4000 ext 5373 mscolaro@nyee.edu
Contact: Ahmad Najafi, MD 646-812-5212 anajafi@nyee.edu
Principal Investigator: Robert Ritch, MD

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

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

More Information

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Responsible Party:	Robert Ritch, Clinical Professor of Ophthalmology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:	NCT03949244 History of Changes
Other Study ID Numbers:	GCO 18-2686
First Posted:	May 14, 2019 Key Record Dates
Last Update Posted:	July 11, 2019
Last Verified:	July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
Time Frame:	Results will be shared upon completion of the study.

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Robert Ritch, Icahn School of Medicine at Mount Sinai:


Nailfold capillary imaging Latanoprost bunod Latanoprost

Additional relevant MeSH terms:

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Glaucoma, Open-Angle Glaucoma Ocular Hypertension	Eye Diseases Latanoprost Antihypertensive Agents

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