A Phase 2 interventional study of VSJ-110 and Placebo in Allergic Conjunctivitis, sponsored by Vanda Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Vanda Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 47 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: VSJ-110
Drug: Placebo
ophthalmic solution
ophthalmic solution
Ocular Itching as Measured by Self-reported Numerical Scales
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)
Time frame: 16 hours, 8 hours, and 15 minutes post-treatment
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
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)
Time frame: 16 hours, 8 hours, and 15 minutes post-treatment
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
Conjunctival 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.
Time frame: 16 hours, 8 hours, and 15 minutes post-treatment
| Milestone | VSJ-110 | Placebo |
|---|---|---|
| Started | 24 | 23 |
| Completed | 22 | 18 |
| Not completed | 2 | 5 |
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)
| score on a scale | VSJ-110 | Placebo |
|---|---|---|
| 16 hours (3(±1) minutes post-challenge) | -0.228 (-0.549 to 0.093) | 0.010 (-0.318 to 0.337) |
| 16 hours (5(±1) minutes post-challenge) | -0.424 (-0.731 to -0.118) | -0.035 (-0.349 to 0.278) |
| 16 hours (7(±1) minutes post-challenge) | -0.450 (-0.711 to -0.190) | -0.182 (-0.448 to 0.084) |
| 8 hours (3(±1) minutes post-challenge) | -0.383 (-0.762 to -0.004) | -0.402 (-0.799 to -0.006) |
| 8 hours (5(±1) minutes post-challenge) | -0.593 (-0.984 to -0.201) | -0.569 (-0.988 to -0.149) |
| 8 hours (7(±1) minutes post-challenge) | -0.698 (-1.073 to -0.322) | -0.772 (-1.165 to -0.379) |
| 15 minutes (3(±1) minutes post-challenge) | 0.039 (-0.272 to 0.349) | -0.007 (-0.340 to 0.326) |
| 15 minutes (5(±1) minutes post-challenge) | -0.248 (-0.588 to 0.093) | -0.140 (-0.505 to 0.225) |
| 15 minutes (7(±1) minutes post-challenge) | -0.422 (-0.767 to -0.077) | -0.314 (-0.684 to 0.056) |
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)
| score on a scale | VSJ-110 | Placebo |
|---|---|---|
| 16 hours (7(±1) minutes post-challenge) | -0.280 (-0.523 to -0.036) | 0.075 (-0.174 to 0.323) |
| 16 hours (15(±1) minutes post-challenge) | -0.366 (-0.572 to -0.160) | -0.108 (-0.318 to 0.103) |
| 16 hours (20(±1) minutes post-challenge) | -0.491 (-0.713 to -0.268) | -0.151 (-0.379 to 0.076) |
| 8 hours (7(±1) minutes post-challenge) | -0.171 (-0.354 to 0.013) | -0.075 (-0.267 to 0.117) |
| 8 hours (15(±1) minutes post-challenge) | -0.208 (-0.359 to -0.057) | -0.201 (-0.359 to -0.043) |
| 8 hours (20(±1) minutes post-challenge) | -0.206 (-0.343 to -0.068) | -0.203 (-0.348 to -0.059) |
| 15 minutes (7(±1) minutes post-challenge) | 0.162 (-0.011 to 0.334) | 0.252 (0.066 to 0.437) |
| 15 minutes (15(±1) minutes post-challenge) | 0.039 (-0.157 to 0.236) | 0.030 (-0.181 to 0.241) |
| 15 minutes (20(±1) minutes post-challenge) | 0.002 (-0.180 to 0.185) | 0.035 (-0.161 to 0.231) |
Conjunctival 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.
| Participants | VSJ-110 | Placebo |
|---|---|---|
| 16 hours (rates across all three time points) | 3 | 0 |
| 8 hours (rates across all three time points) | 1 | 0 |
| 15 minutes (rates across all three time points) | 0 | 0 |
| 16 hours (rates across two out of the three timepoints) | 5 | 1 |
| 8 hours (rates across two out of the three timepoints) | 1 | 0 |
| 15 minutes (rates across two out of the three timepoints) | 0 | 1 |
Collected over AE data was collected during the 4 week treatment period plus a 7 day follow up period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VSJ-110 Solution | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) |
| Placebo Solution | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) |
| Event | VSJ-110 Solution | Placebo Solution |
|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/24 | 1/23 |
| Event | VSJ-110 Solution | Placebo Solution |
|---|---|---|
| Visual acuity reducedEye disorders | 2/24 | 0/23 |
| Age, Categorical(Participants) | VSJ-110 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 21 | 40 |
| >=65 years | 5 | 2 | 7 |
| Sex: Female, Male(Participants) | VSJ-110 | Placebo | Total |
|---|---|---|---|
| Female | 15 | 12 | 27 |
| Male | 9 | 11 | 20 |
| Race/Ethnicity, Customized(Participants) | VSJ-110 | Placebo | Total |
|---|---|---|---|
| Number Analyzed — American Indian or Alaska Native | 0 | 1 | 1 |
| Number Analyzed — Asian | 0 | 0 | 0 |
| Number Analyzed — Black or African American | 0 | 2 | 2 |
| Number Analyzed — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Number Analyzed — White | 23 | 19 | 42 |
| Number Analyzed — Other | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in May 2021, 6 months.
Results were first posted in Sep 2025, 4 years 3 months after primary completion.
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Studies of the drug tested here: VSJ-110