Trial Outcomes & Findings for Nailfold Capillary Blood Flow With Latanoprost Bunod (NCT NCT03949244)
NCT ID: NCT03949244
Last Updated: 2021-09-29
Results Overview
NFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
baseline and 15 minutes
Results posted on
2021-09-29
Participant Flow
Recruitment occurred at New York Eye and Ear Infirmary of Mount Sinai
Participant milestones
| Measure |
Latanoprost 0.005%
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%
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%
Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
21
|
14
|
|
Overall Study
COMPLETED
|
12
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nailfold Capillary Blood Flow With Latanoprost Bunod
Baseline characteristics by cohort
| Measure |
Latanoprost 0.005%
n=12 Participants
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%
n=21 Participants
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%
n=14 Participants
Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.08 years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
66.95 years
STANDARD_DEVIATION 8.86 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
66.84 years
STANDARD_DEVIATION 7.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 15 minutesNFC blood flow at baseline and at 15 minutes after NF application to the 4th digit of the nondominant hand.
Outcome measures
| Measure |
Latanoprost 0.005%
n=12 Participants
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%
n=21 Participants
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%
n=14 Participants
Normal saline 0.9% to the nailfold and images of the blood flow in the nailfold capillaries acquired via nailfold capillaroscopy.
|
|---|---|---|---|
|
NFC Blood Flow at Baseline and 15 Minutes
15 minutes
|
60.50 pL/s
Standard Deviation 42.81
|
75.57 pL/s
Standard Deviation 44.68
|
69.70 pL/s
Standard Deviation 41.46
|
|
NFC Blood Flow at Baseline and 15 Minutes
Baseline
|
72.52 pL/s
Standard Deviation 37.76
|
83.94 pL/s
Standard Deviation 78.31
|
93.01 pL/s
Standard Deviation 61.4
|
Adverse Events
Latanoprost 0.005%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Latanoprost Bunod 0.024%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline 0.9%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place