Trial Outcomes & Findings for Study of VVN001 Ophthalmic Solution in Dry Eye Disease (NCT NCT04556838)
NCT ID: NCT04556838
Last Updated: 2023-12-13
Results Overview
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
169 participants
Primary outcome timeframe
Day 84
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
VVN001, 1%
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
56
|
|
Overall Study
COMPLETED
|
53
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
5
|
Reasons for withdrawal
| Measure |
VVN001, 1%
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Subject travel
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Study of VVN001 Ophthalmic Solution in Dry Eye Disease
Baseline characteristics by cohort
| Measure |
VVN001, 1%
n=57 Participants
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=56 Participants
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=56 Participants
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 13.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
127 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
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 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
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Inferior Corneal Fluorescein Staining
|
2.45 units on a scale (0 none to 4 severe)
STANDARD_DEVIATION 0.532 • n=5 Participants
|
2.45 units on a scale (0 none to 4 severe)
STANDARD_DEVIATION 0.537 • n=7 Participants
|
2.44 units on a scale (0 none to 4 severe)
STANDARD_DEVIATION 0.548 • n=5 Participants
|
2.44 units on a scale (0 none to 4 severe)
STANDARD_DEVIATION 0.536 • n=4 Participants
|
|
Eye Dryness Visual Analog Scale
|
66.5 units on a scale
STANDARD_DEVIATION 18.59 • n=5 Participants
|
66.2 units on a scale
STANDARD_DEVIATION 15.43 • n=7 Participants
|
64.9 units on a scale
STANDARD_DEVIATION 17.34 • n=5 Participants
|
65.9 units on a scale
STANDARD_DEVIATION 17.09 • n=4 Participants
|
|
Total Corneal Fluorescein Staining
|
6.64 units on a scale
STANDARD_DEVIATION 3.24 • n=5 Participants
|
6.96 units on a scale
STANDARD_DEVIATION 2.97 • n=7 Participants
|
6.18 units on a scale
STANDARD_DEVIATION 2.92 • n=5 Participants
|
6.59 units on a scale
STANDARD_DEVIATION 3.04 • n=4 Participants
|
|
Regional corneal fluorescein staining
|
2.45 units on a scale
STANDARD_DEVIATION 0.532 • n=5 Participants
|
2.45 units on a scale
STANDARD_DEVIATION 0.537 • n=7 Participants
|
2.44 units on a scale
STANDARD_DEVIATION 0.548 • n=5 Participants
|
2.44 units on a scale
STANDARD_DEVIATION 0.536 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: Sample size reflects number of subjects evaluable at Day 84
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Outcome measures
| Measure |
VVN001, 1%
n=54 Participants
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=53 Participants
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=51 Participants
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Inferior Corneal Fluorescein Staining
|
-0.69 score on a scale
Standard Deviation 0.77
|
-.97 score on a scale
Standard Deviation 0.81
|
-0.72 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 84Population: Sample size reflects number of subjects evaluable at Day 84
Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20.
Outcome measures
| Measure |
VVN001, 1%
n=53 Participants
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=53 Participants
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=51 Participants
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Total Corneal Fluorescein Staining
|
-1.75 score on a scale
Standard Deviation 2.39
|
-2.60 score on a scale
Standard Deviation 3.25
|
-0.79 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Day 84Population: Sample size reflects number of subjects evaluable at Day 84
Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Outcome measures
| Measure |
VVN001, 1%
n=53 Participants
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=53 Participants
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=51 Participants
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Regional Corneal Fluorescein Staining
|
-0.20 score on a scale
Standard Deviation 0.72
|
-0.52 score on a scale
Standard Deviation 0.87
|
-0.11 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Day 84Population: Sample size reflects number of subjects evaluable at Day 84
Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100..
Outcome measures
| Measure |
VVN001, 1%
n=53 Participants
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=54 Participants
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=51 Participants
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Eye Dryness
|
-28.7 score on a scale
Standard Deviation 27.4
|
-22.2 score on a scale
Standard Deviation 25.02
|
-19.9 score on a scale
Standard Deviation 29.0
|
Adverse Events
VVN001, 1%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VVN001, 5%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VVN001, 1%
n=56 participants at risk
VVN001, 1% ophthalmic solution
VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1%
|
VVN001, 5%
n=57 participants at risk
VVN001, 5% ophthalmic solution
VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5%
|
Vehicle
n=56 participants at risk
VVN001 Ophthalmic Solution Placebo
Vehicle: VVN001 Ophthalmic Solution Vehicle
|
|---|---|---|---|
|
Eye disorders
Chalzion
|
0.00%
0/56 • 84 days
|
3.5%
2/57 • Number of events 2 • 84 days
|
0.00%
0/56 • 84 days
|
|
Eye disorders
Instillation site pain
|
5.4%
3/56 • Number of events 3 • 84 days
|
1.8%
1/57 • Number of events 2 • 84 days
|
3.6%
2/56 • Number of events 2 • 84 days
|
|
Gastrointestinal disorders
Dysguesia
|
0.00%
0/56 • 84 days
|
5.3%
3/57 • Number of events 3 • 84 days
|
0.00%
0/56 • 84 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place