Glaucoma, Open-AnglePhase 4NCT03949244
Nailfold Capillary Blood Flow With Latanoprost Bunod
A Phase 4 study testing Latanoprost 0.005%, Latanoprost bunod 0.024% and Normal saline 0.9% in people with Glaucoma, Open-Angle, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Latanoprost 0.005%, Latanoprost bunod 0.024% and Normal saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 1 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of non-POAG forms of glaucoma
- Pregnancy
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
About this study
Official title: Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
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.
Read the 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
- Being tested
- Latanoprost 0.005%, Latanoprost bunod 0.024%, Normal saline 0.9%, Nailfold capillaroscopy
- Keywords
- Nailfold capillary imaging, Latanoprost bunod, Latanoprost
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost 0.005%Drug
Also called Xalatan
Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
Latanoprost bunod 0.024%Drug
Also called Vyzulta, LTB
Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
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.
Nailfold capillaroscopyDiagnostic test
Also called NFC
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.
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost 0.005% | Active comparator | Latanoprost 0.005% drops to the nailfold. Receives: Drug: Latanoprost 0.005%; Diagnostic Test: Nailfold capillaroscopy |
| Latanoprost bunod 0.024% | Experimental | Latanoprost bunod 0.024% drops to the nailfold. Receives: Drug: Latanoprost bunod 0.024%; Diagnostic Test: Nailfold capillaroscopy |
| Normal saline 0.9% | Placebo comparator | Normal saline 0.9% to the nailfold. Receives: Drug: Normal saline 0.9%; Diagnostic Test: Nailfold capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start15 Aug 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Tsai, Icahn School of Medicine at Mount Sinai
- Investigators
- Robert Ritch, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949244
- Sponsor's protocol ID
- GCO 18-2686
- Status last verified
- Sep 2021
- First submitted
- 12 May 2019
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow
- ClinicalTrials.gov ID
- NCT03949244
- Acronym / sponsor ID
- GCO 18-2686
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Nailfold capillary imaging, Latanoprost bunod, Latanoprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latanoprost 0.005% | Active comparator | Drug: Latanoprost 0.005%, Diagnostic Test: Nailfold capillaroscopyLatanoprost 0.005% drops to the nailfold. |
| Latanoprost bunod 0.024% | Experimental | Drug: Latanoprost bunod 0.024%, Diagnostic Test: Nailfold capillaroscopyLatanoprost bunod 0.024% drops to the nailfold. |
| Normal saline 0.9% | Placebo comparator | Drug: Normal saline 0.9%, Diagnostic Test: Nailfold capillaroscopyNormal saline 0.9% to the nailfold. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- History of non-POAG forms of glaucoma
- Pregnancy
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost 0.005%Also: XalatanLatanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired. | Drug | Latanoprost 0.005% |
| Latanoprost bunod 0.024%Also: Vyzulta, LTBLatanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired. | Drug | Latanoprost bunod 0.024% |
| 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. | Drug | Normal saline 0.9% |
| Nailfold capillaroscopyAlso: NFCAn 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. | Diagnostic test | Latanoprost 0.005%, Latanoprost bunod 0.024%, Normal saline 0.9% |
Primary outcome
NFC Blood Flow at Baseline and 15 Minutes
Time frame: baseline and 15 minutes
NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ritch, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latanoprost 0.005%, Latanoprost bunod 0.024% and Normal saline 0.9% in people with Glaucoma, Open-Angle, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NFC Blood Flow at Baseline and 15 Minutes (time frame: baseline and 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.