Nailfold Capillary Blood Flow With Latanoprost Bunod

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT03949244
Collaborator
(none)
47
1
3
13.6
3.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Actual Enrollment :
47 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
Actual Study Start Date :
Aug 15, 2019
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Oct 1, 2020

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 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.

    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 Names:
  • 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 Names:
  • NFC
  • Outcome Measures

    Primary Outcome Measures

    1. NFC Blood Flow at Baseline and 15 Minutes [baseline and 15 minutes]

      NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 New York Eye and Ear Infirmary of Mount Sinai New York New York United States 10003

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    James Tsai, Professor and System Chair of Ophthalmology, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT03949244
    Other Study ID Numbers:
    • GCO 18-2686
    First Posted:
    May 14, 2019
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by James Tsai, Professor and System Chair of Ophthalmology, Icahn School of Medicine at Mount Sinai
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Recruitment occurred at New York Eye and Ear Infirmary of Mount Sinai
    Pre-assignment Detail
    Arm/Group Title Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Arm/Group Description Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired. 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. Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy. Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
    Period Title: Overall Study
    STARTED 12 21 14
    COMPLETED 12 21 14
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9% Total
    Arm/Group Description Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired. 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. Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy. Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy. Total of all reporting groups
    Overall Participants 12 21 14 47
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.08
    (5.95)
    66.95
    (8.86)
    66.5
    (8.50)
    66.84
    (7.77)
    Sex: Female, Male (Count of Participants)
    Female
    7
    58.3%
    14
    66.7%
    8
    57.1%
    29
    61.7%
    Male
    5
    41.7%
    7
    33.3%
    6
    42.9%
    18
    38.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    25%
    5
    23.8%
    3
    21.4%
    11
    23.4%
    Not Hispanic or Latino
    9
    75%
    16
    76.2%
    11
    78.6%
    36
    76.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    8.3%
    4
    19%
    2
    14.3%
    7
    14.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    16.7%
    2
    9.5%
    1
    7.1%
    5
    10.6%
    White
    9
    75%
    14
    66.7%
    10
    71.4%
    33
    70.2%
    More than one race
    0
    0%
    1
    4.8%
    1
    7.1%
    2
    4.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title NFC Blood Flow at Baseline and 15 Minutes
    Description NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.
    Time Frame baseline and 15 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Arm/Group Description Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired. 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. Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy. Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
    Measure Participants 12 21 14
    Baseline
    72.52
    (37.76)
    83.94
    (78.31)
    93.01
    (61.4)
    15 minutes
    60.50
    (42.81)
    75.57
    (44.68)
    69.70
    (41.46)

    Adverse Events

    Time Frame 15 minutes
    Adverse Event Reporting Description
    Arm/Group Title Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Arm/Group Description Latanoprost 0.005% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired. 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. Latanoprost bunod 0.024% drops applied to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy. Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
    All Cause Mortality
    Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/21 (0%) 0/14 (0%)
    Serious Adverse Events
    Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/21 (0%) 0/14 (0%)
    Other (Not Including Serious) Adverse Events
    Latanoprost 0.005% Latanoprost Bunod 0.024% Normal Saline 0.9%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/21 (0%) 0/14 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Harriet Lloyd
    Organization Icahn School of Medicine at Mount Sinai
    Phone 212-979-4672
    Email hlloyd@nyee.edu
    Responsible Party:
    James Tsai, Professor and System Chair of Ophthalmology, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT03949244
    Other Study ID Numbers:
    • GCO 18-2686
    First Posted:
    May 14, 2019
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021