Trial Outcomes & Findings for Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery (NCT NCT06164743)
NCT ID: NCT06164743
Last Updated: 2025-06-10
Results Overview
Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (\>50 cells in field). Note - higher values represent a WORSE outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Day 14
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
VVN461 1.0%
VVN461 Ophthalmic Solution, 1.0%
VVN461 Ophthalmic Solution 1.0%: Topical ocular drug
|
VVN461 0.5%
VVN461 Ophthalmic Solution, 0.5%
VVN461 Ophthalmic Solution 0.5%: Topical ocular drug
|
Vehicle
VVN461 Vehicle
Vehicle: Topical ocular drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery
Baseline characteristics by cohort
| Measure |
VVN461 1.0%
n=30 Participants
VVN461 Ophthalmic Solution, 1.0%
VVN461 Ophthalmic Solution 1.0%: Topical ocular drug
|
VVN461 0.5%
n=30 Participants
VVN461 Ophthalmic Solution, 0.5%
VVN461 Ophthalmic Solution 0.5%: Topical ocular drug
|
Vehicle
n=31 Participants
VVN461 Vehicle
Vehicle: Topical ocular drug
|
Total
n=91 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
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 7.28 • n=99 Participants
|
68.5 years
STANDARD_DEVIATION 8.51 • n=107 Participants
|
69.8 years
STANDARD_DEVIATION 7.94 • n=206 Participants
|
69.1 years
STANDARD_DEVIATION 6.79 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
36 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
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 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
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
31 participants
n=206 Participants
|
91 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 14Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (\>50 cells in field). Note - higher values represent a WORSE outcome.
Outcome measures
| Measure |
VVN461 1.0%
n=30 Participants
VVN461 Ophthalmic Solution, 1.0%
VVN461 Ophthalmic Solution 1.0%: Topical ocular drug
|
VVN461 0.5%
n=30 Participants
VVN461 Ophthalmic Solution, 0.5%
VVN461 Ophthalmic Solution 0.5%: Topical ocular drug
|
Vehicle
n=31 Participants
VVN461 Vehicle
Vehicle: Topical ocular drug
|
|---|---|---|---|
|
Anterior Chamber Cell: Categorical Cure
|
18 Participants
|
16 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 21Number of subjects with Adverse Events
Outcome measures
| Measure |
VVN461 1.0%
n=30 Participants
VVN461 Ophthalmic Solution, 1.0%
VVN461 Ophthalmic Solution 1.0%: Topical ocular drug
|
VVN461 0.5%
n=30 Participants
VVN461 Ophthalmic Solution, 0.5%
VVN461 Ophthalmic Solution 0.5%: Topical ocular drug
|
Vehicle
n=31 Participants
VVN461 Vehicle
Vehicle: Topical ocular drug
|
|---|---|---|---|
|
Safety of VVN461
|
2 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
VVN461 1.0%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VVN461 0.5%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
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