A Phase 4 interventional study of Latanoprost 0.005% and Latanoprost bunod 0.024% in Glaucoma, Open-Angle, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Basic science
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.
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.
929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.
This study's enrollment of 47 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
Latanoprost 0.005% drops to the nailfold.
Drug: Latanoprost 0.005% · Diagnostic Test: Nailfold capillaroscopy
Latanoprost bunod 0.024% drops to the nailfold.
Drug: Latanoprost bunod 0.024% · Diagnostic Test: Nailfold capillaroscopy
Normal saline 0.9% to the nailfold.
Drug: Normal saline 0.9% · Diagnostic Test: Nailfold capillaroscopy
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 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
Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
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
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.
Time frame: baseline and 15 minutes
Recruitment occurred at New York Eye and Ear Infirmary of Mount Sinai
| Milestone | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% |
|---|---|---|---|
| Started | 12 | 21 | 14 |
| Completed | 12 | 21 | 14 |
| Not completed | 0 | 0 | 0 |
NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.
| pL/s | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% |
|---|---|---|---|
| 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 |
Collected over 15 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Latanoprost 0.005% | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Latanoprost Bunod 0.024% | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Normal Saline 0.9% | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% | Total |
|---|---|---|---|---|
| Mean | 67.08 ± 5.95 | 66.95 ± 8.86 | 66.5 ± 8.50 | 66.84 ± 7.77 |
| Sex: Female, Male(Participants) | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% | Total |
|---|---|---|---|---|
| Female | 7 | 14 | 8 | 29 |
| Male | 5 | 7 | 6 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 3 | 11 |
| Not Hispanic or Latino | 9 | 16 | 11 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Latanoprost 0.005% | Latanoprost Bunod 0.024% | Normal Saline 0.9% | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 4 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 1 | 5 |
| White | 9 | 14 | 10 | 33 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Plan to share: 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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Icahn School of Medicine at Mount Sinai