Trial Outcomes & Findings for A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure (NCT NCT05451329)
NCT ID: NCT05451329
Last Updated: 2024-01-17
Results Overview
mmHg
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Results posted on
2024-01-17
Participant Flow
Participant milestones
| Measure |
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Investigational Product Lot exchange
|
1
|
1
|
0
|
Baseline Characteristics
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Baseline characteristics by cohort
| Measure |
VVN539 Ophthalmic Solution 0.02%
n=23 Participants
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
n=22 Participants
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
n=23 Participants
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
65.1 years
STANDARD_DEVIATION 13.4 • n=107 Participants
|
64.7 years
STANDARD_DEVIATION 16.4 • n=206 Participants
|
66.3 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
23 participants
n=206 Participants
|
68 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21Population: Full Analysis Set
mmHg
Outcome measures
| Measure |
VVN539 Ophthalmic Solution 0.02%
n=23 Participants
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
n=22 Participants
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
n=23 Participants
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
|---|---|---|---|
|
Mean Intraocular Pressure
0800 AM Day 7
|
21.8 mmHg
Standard Deviation 4.6
|
20.5 mmHg
Standard Deviation 2.5
|
23.4 mmHg
Standard Deviation 3.9
|
|
Mean Intraocular Pressure
1000 AM Day 7
|
19.7 mmHg
Standard Deviation 4.7
|
19.0 mmHg
Standard Deviation 2.8
|
22.0 mmHg
Standard Deviation 3.1
|
|
Mean Intraocular Pressure
0400 PM Day 7
|
19.1 mmHg
Standard Deviation 4.1
|
18.1 mmHg
Standard Deviation 2.6
|
21.7 mmHg
Standard Deviation 2.9
|
|
Mean Intraocular Pressure
0800 AM Day 14
|
21.1 mmHg
Standard Deviation 5.0
|
19.6 mmHg
Standard Deviation 3.9
|
23.1 mmHg
Standard Deviation 3.5
|
|
Mean Intraocular Pressure
1000 AM Day 14
|
19.9 mmHg
Standard Deviation 5.1
|
18.2 mmHg
Standard Deviation 4.3
|
22.1 mmHg
Standard Deviation 3.0
|
|
Mean Intraocular Pressure
0400 PM Day 14
|
19.7 mmHg
Standard Deviation 5.2
|
18.0 mmHg
Standard Deviation 2.8
|
22.0 mmHg
Standard Deviation 3.9
|
|
Mean Intraocular Pressure
0800 AM Day 21
|
19.7 mmHg
Standard Deviation 3.6
|
19.2 mmHg
Standard Deviation 2.8
|
23.4 mmHg
Standard Deviation 3.9
|
|
Mean Intraocular Pressure
1000 AM Day 21
|
19.2 mmHg
Standard Deviation 5.0
|
19.1 mmHg
Standard Deviation 3.3
|
22.6 mmHg
Standard Deviation 3.2
|
|
Mean Intraocular Pressure
0400 PM Day 21
|
18.7 mmHg
Standard Deviation 5.2
|
18.8 mmHg
Standard Deviation 3.0
|
21.7 mmHg
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21mmHg
Outcome measures
| Measure |
VVN539 Ophthalmic Solution 0.02%
n=23 Participants
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
n=22 Participants
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
n=23 Participants
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
|---|---|---|---|
|
Mean Change in Intraocular Pressure From Baseline
0800 AM Day 7
|
-3.6 mmHg
Standard Deviation 4.1
|
-4.1 mmHg
Standard Deviation 2.7
|
-2.0 mmHg
Standard Deviation 2.8
|
|
Mean Change in Intraocular Pressure From Baseline
1000 AM Day 7
|
-5.3 mmHg
Standard Deviation 4.2
|
-5.0 mmHg
Standard Deviation 3.0
|
-2.3 mmHg
Standard Deviation 3.0
|
|
Mean Change in Intraocular Pressure From Baseline
0400 PM Day 7
|
-3.3 mmHg
Standard Deviation 3.5
|
-4.6 mmHg
Standard Deviation 2.6
|
-1.3 mmHg
Standard Deviation 2.2
|
|
Mean Change in Intraocular Pressure From Baseline
0800 AM Day 14
|
-4.3 mmHg
Standard Deviation 4.3
|
-5.0 mmHg
Standard Deviation 4.0
|
-2.2 mmHg
Standard Deviation 2.7
|
|
Mean Change in Intraocular Pressure From Baseline
1000 PM Day 14
|
-5.1 mmHg
Standard Deviation 4.2
|
-5.8 mmHg
Standard Deviation 3.6
|
-2.1 mmHg
Standard Deviation 2.3
|
|
Mean Change in Intraocular Pressure From Baseline
0400 PM Day 14
|
-2.7 mmHg
Standard Deviation 4.6
|
-4.8 mmHg
Standard Deviation 3.3
|
-0.9 mmHg
Standard Deviation 3.5
|
|
Mean Change in Intraocular Pressure From Baseline
0800 AM Day 21
|
-5.7 mmHg
Standard Deviation 2.7
|
-5.4 mmHg
Standard Deviation 2.8
|
-2.0 mmHg
Standard Deviation 3.3
|
|
Mean Change in Intraocular Pressure From Baseline
1000 AM Day 21
|
-5.7 mmHg
Standard Deviation 3.9
|
-5.0 mmHg
Standard Deviation 3.7
|
-1.5 mmHg
Standard Deviation 2.4
|
|
Mean Change in Intraocular Pressure From Baseline
0400 PM Day 21
|
-3.7 mmHg
Standard Deviation 4.3
|
-3.9 mmHg
Standard Deviation 2.8
|
-1.2 mmHg
Standard Deviation 3.4
|
Adverse Events
VVN539 Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
VVN539 Ophthalmic Solution 0.04%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
VVN539 Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VVN539 Ophthalmic Solution 0.02%
n=23 participants at risk
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.02%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution 0.04%
n=22 participants at risk
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution 0.04%: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
VVN539 Ophthalmic Solution Vehicle
n=23 participants at risk
VVN539 Ophthalmic Solution Vehicle
VVN539 Ophthalmic Solution Vehicle: Once a day \[q.d.\] in the morning, q.d. in the evening and twice a day \[b.i.d.\]) will be tested for 7-9 days
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
47.8%
11/23 • Number of events 11 • 21 days
|
45.5%
10/22 • Number of events 10 • 21 days
|
4.3%
1/23 • Number of events 1 • 21 days
|
|
Eye disorders
Ocular hyperaemia
|
13.0%
3/23 • Number of events 3 • 21 days
|
22.7%
5/22 • Number of events 5 • 21 days
|
0.00%
0/23 • 21 days
|
|
Eye disorders
Eye pain
|
4.3%
1/23 • Number of events 1 • 21 days
|
13.6%
3/22 • Number of events 3 • 21 days
|
0.00%
0/23 • 21 days
|
|
Eye disorders
Eye irritation
|
4.3%
1/23 • Number of events 1 • 21 days
|
9.1%
2/22 • Number of events 2 • 21 days
|
0.00%
0/23 • 21 days
|
|
Eye disorders
Vision blurred
|
4.3%
1/23 • Number of events 1 • 21 days
|
9.1%
2/22 • Number of events 2 • 21 days
|
0.00%
0/23 • 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All investigators will work collaboratively with the Sponsor on presentations and publications.
- Publication restrictions are in place
Restriction type: OTHER