Nailfold Capillary Blood Flow With Latanoprost Bunod
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Latanoprost 0.005%
Latanoprost bunod 0.024%
Normal saline 0.9%
Nailfold capillaroscopy
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma, Open-Angle focused on measuring Nailfold capillary imaging, Latanoprost bunod, Latanoprost
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
Sites / Locations
- New York Eye and Ear Infirmary of Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Latanoprost 0.005%
Latanoprost bunod 0.024%
Normal saline 0.9%
Arm Description
Latanoprost 0.005% drops to the nailfold.
Latanoprost bunod 0.024% drops to the nailfold.
Normal saline 0.9% to the nailfold.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03949244
First Posted
May 12, 2019
Last Updated
September 1, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03949244
Brief Title
Nailfold Capillary Blood Flow With Latanoprost Bunod
Official Title
Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
Nailfold capillary imaging, Latanoprost bunod, Latanoprost
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latanoprost 0.005%
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005% drops to the nailfold.
Arm Title
Latanoprost bunod 0.024%
Arm Type
Experimental
Arm Description
Latanoprost bunod 0.024% drops to the nailfold.
Arm Title
Normal saline 0.9%
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9% to the nailfold.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Other Intervention Name(s)
Xalatan
Intervention Description
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
Intervention Name(s)
Latanoprost bunod 0.024%
Other Intervention Name(s)
Vyzulta, LTB
Intervention Description
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
Intervention Name(s)
Normal saline 0.9%
Intervention Description
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
Diagnostic Test
Intervention Name(s)
Nailfold capillaroscopy
Other Intervention Name(s)
NFC
Intervention Description
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.
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ritch, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Nailfold Capillary Blood Flow With Latanoprost Bunod
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