Nailfold Capillary Blood Flow With Latanoprost Bunod

NCT03949244 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 18-2686
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle

Keywords

Nailfold capillary imaging; Latanoprost bunod; Latanoprost

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Latanoprost 0.005%

ACTIVE COMPARATOR

Latanoprost 0.005% drops to the nailfold.

Drug: Latanoprost 0.005%; Diagnostic Test: Nailfold capillaroscopy

Latanoprost bunod 0.024%

EXPERIMENTAL

Latanoprost bunod 0.024% drops to the nailfold.

Drug: Latanoprost bunod 0.024%; Diagnostic Test: Nailfold capillaroscopy

Normal saline 0.9%

PLACEBO COMPARATOR

Normal saline 0.9% to the nailfold.

Drug: Normal saline 0.9%; Diagnostic Test: Nailfold capillaroscopy

Interventions

Latanoprost 0.005% DRUG

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

Also known as: Xalatan

Latanoprost 0.005%

Latanoprost bunod 0.024% DRUG

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

Also known as: Vyzulta, LTB

Latanoprost bunod 0.024%

Normal saline 0.9% DRUG

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

Normal saline 0.9%

Nailfold capillaroscopy 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.

Also known as: NFC

Latanoprost 0.005%; Latanoprost bunod 0.024%; Normal saline 0.9%

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Latanoprost; BOL 303259-X; Saline Solution; Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Results Point of Contact

• Title: Harriet Lloyd
• Organization: Icahn School of Medicine at Mount Sinai

hlloyd@nyee.edu

212-979-4672

Study Officials

• Robert Ritch, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chair of Ophthalmology

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 14, 2019
• Study Start: August 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 29, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Results will be shared upon completion of the study.

Locations

US (1)