Nailfold Capillary Blood Flow With Latanoprost Bunod

NCT ID: NCT03949244

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2020-10-01

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Latanoprost 0.005%

Latanoprost 0.005% drops to the nailfold.

Group Type: ACTIVE_COMPARATOR

Latanoprost 0.005%

Intervention Type: DRUG

Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.

Nailfold capillaroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Latanoprost bunod 0.024%

Latanoprost bunod 0.024% drops to the nailfold.

Group Type: EXPERIMENTAL

Latanoprost bunod 0.024%

Intervention Type: DRUG

Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.

Nailfold capillaroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Normal saline 0.9%

Normal saline 0.9% to the nailfold.

Group Type: PLACEBO_COMPARATOR

Normal saline 0.9%

Intervention Type: DRUG

Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.

Nailfold capillaroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Xalatan; Vyzulta; LTB; NFC

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

James Tsai

Professor and System Chair of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Ritch, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 18-2686

Identifier Type: -

Identifier Source: org_study_id