Trial Outcomes & Findings for Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies (NCT NCT04622345)
NCT ID: NCT04622345
Last Updated: 2025-09-11
Results Overview
Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
16 hours, 8 hours, and 15 minutes post-treatment
Results posted on
2025-09-11
Participant Flow
Participant milestones
| Measure |
VSJ-110
VSJ-110 Ophthalmic Solution
|
Placebo
Placebo Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
Baseline characteristics by cohort
| Measure |
VSJ-110
n=24 Participants
VSJ-110 Ophthalmic Solution
|
Placebo
n=23 Participants
Placebo Ophthalmic Solution
|
Total
n=47 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · White
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 hours, 8 hours, and 15 minutes post-treatmentPopulation: Efficacy analysis performed on ITT and PP populations
Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching)
Outcome measures
| Measure |
VSJ-110
n=24 Participants
VSJ-110 Ophthalmic Solution
|
Placebo
n=23 Participants
Placebo Ophthalmic Solution
|
|---|---|---|
|
Ocular Itching as Measured by Self-reported Numerical Scales
16 hours (3(±1) minutes post-challenge)
|
-0.228 score on a scale
Interval -0.549 to 0.093
|
0.010 score on a scale
Interval -0.318 to 0.337
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
16 hours (5(±1) minutes post-challenge)
|
-0.424 score on a scale
Interval -0.731 to -0.118
|
-0.035 score on a scale
Interval -0.349 to 0.278
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
16 hours (7(±1) minutes post-challenge)
|
-0.450 score on a scale
Interval -0.711 to -0.19
|
-0.182 score on a scale
Interval -0.448 to 0.084
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
8 hours (3(±1) minutes post-challenge)
|
-0.383 score on a scale
Interval -0.762 to -0.004
|
-0.402 score on a scale
Interval -0.799 to -0.006
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
8 hours (5(±1) minutes post-challenge)
|
-0.593 score on a scale
Interval -0.984 to -0.201
|
-0.569 score on a scale
Interval -0.988 to -0.149
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
8 hours (7(±1) minutes post-challenge)
|
-0.698 score on a scale
Interval -1.073 to -0.322
|
-0.772 score on a scale
Interval -1.165 to -0.379
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
15 minutes (3(±1) minutes post-challenge)
|
0.039 score on a scale
Interval -0.272 to 0.349
|
-0.007 score on a scale
Interval -0.34 to 0.326
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
15 minutes (5(±1) minutes post-challenge)
|
-0.248 score on a scale
Interval -0.588 to 0.093
|
-0.140 score on a scale
Interval -0.505 to 0.225
|
|
Ocular Itching as Measured by Self-reported Numerical Scales
15 minutes (7(±1) minutes post-challenge)
|
-0.422 score on a scale
Interval -0.767 to -0.077
|
-0.314 score on a scale
Interval -0.684 to 0.056
|
PRIMARY outcome
Timeframe: 16 hours, 8 hours, and 15 minutes post-treatmentPopulation: Efficacy analysis performed on ITT and PP populations
Change from baseline in conjunctival redness evaluated by the investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more redness)
Outcome measures
| Measure |
VSJ-110
n=24 Participants
VSJ-110 Ophthalmic Solution
|
Placebo
n=23 Participants
Placebo Ophthalmic Solution
|
|---|---|---|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
16 hours (7(±1) minutes post-challenge)
|
-0.280 score on a scale
Interval -0.523 to -0.036
|
0.075 score on a scale
Interval -0.174 to 0.323
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
16 hours (15(±1) minutes post-challenge)
|
-0.366 score on a scale
Interval -0.572 to -0.16
|
-0.108 score on a scale
Interval -0.318 to 0.103
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
16 hours (20(±1) minutes post-challenge)
|
-0.491 score on a scale
Interval -0.713 to -0.268
|
-0.151 score on a scale
Interval -0.379 to 0.076
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
8 hours (7(±1) minutes post-challenge)
|
-0.171 score on a scale
Interval -0.354 to 0.013
|
-0.075 score on a scale
Interval -0.267 to 0.117
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
8 hours (15(±1) minutes post-challenge)
|
-0.208 score on a scale
Interval -0.359 to -0.057
|
-0.201 score on a scale
Interval -0.359 to -0.043
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
8 hours (20(±1) minutes post-challenge)
|
-0.206 score on a scale
Interval -0.343 to -0.068
|
-0.203 score on a scale
Interval -0.348 to -0.059
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
15 minutes (7(±1) minutes post-challenge)
|
0.162 score on a scale
Interval -0.011 to 0.334
|
0.252 score on a scale
Interval 0.066 to 0.437
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
15 minutes (15(±1) minutes post-challenge)
|
0.039 score on a scale
Interval -0.157 to 0.236
|
0.030 score on a scale
Interval -0.181 to 0.241
|
|
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
15 minutes (20(±1) minutes post-challenge)
|
0.002 score on a scale
Interval -0.18 to 0.185
|
0.035 score on a scale
Interval -0.161 to 0.231
|
SECONDARY outcome
Timeframe: 16 hours, 8 hours, and 15 minutes post-treatmentConjunctival redness responder rates evaluated by the investigator at 7(±1), 15(±1), and 20(±1) minutes post allergen challenge. A responder is defined as meeting 1, 1.5, or 2 points reduction from baseline, or complete response in all three time points or at least two out of the three timepoints.
Outcome measures
| Measure |
VSJ-110
n=24 Participants
VSJ-110 Ophthalmic Solution
|
Placebo
n=23 Participants
Placebo Ophthalmic Solution
|
|---|---|---|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
16 hours (rates across all three time points)
|
3 Participants
|
0 Participants
|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
15 minutes (rates across two out of the three timepoints)
|
0 Participants
|
1 Participants
|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
8 hours (rates across all three time points)
|
1 Participants
|
0 Participants
|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
15 minutes (rates across all three time points)
|
0 Participants
|
0 Participants
|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
16 hours (rates across two out of the three timepoints)
|
5 Participants
|
1 Participants
|
|
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
8 hours (rates across two out of the three timepoints)
|
1 Participants
|
0 Participants
|
Adverse Events
VSJ-110 Solution
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Solution
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VSJ-110 Solution
n=24 participants at risk
VSJ-110: ophthalmic solution
|
Placebo Solution
n=23 participants at risk
Placebo: ophthalmic solution
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/24 • AE data was collected during the 4 week treatment period plus a 7 day follow up period.
|
4.3%
1/23 • Number of events 1 • AE data was collected during the 4 week treatment period plus a 7 day follow up period.
|
Other adverse events
| Measure |
VSJ-110 Solution
n=24 participants at risk
VSJ-110: ophthalmic solution
|
Placebo Solution
n=23 participants at risk
Placebo: ophthalmic solution
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
8.3%
2/24 • Number of events 2 • AE data was collected during the 4 week treatment period plus a 7 day follow up period.
|
0.00%
0/23 • AE data was collected during the 4 week treatment period plus a 7 day follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place