Allergic Conjunctivitis
Conditions
Brief summary
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
Interventions
DRUGVSJ-110
ophthalmic solution
DRUGPlacebo
ophthalmic solution
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age of either gender and any race * Able to provide written informed consent and sign the HIPAA form * Willing and able to follow all instructions and attend all study visits
Exclusion criteria
* Able and willing to avoid all disallowed medications during washout and study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours, 8 hours, and 15 minutes post-treatment | 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) |
| Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours, 8 hours, and 15 minutes post-treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 16 hours, 8 hours, and 15 minutes post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VSJ-110 VSJ-110 Ophthalmic Solution | 24 |
| Placebo Placebo Ophthalmic Solution | 23 |
| Total | 47 |
Baseline characteristics
| Characteristic | VSJ-110 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 40 Participants |
| Race/Ethnicity, Customized Number Analyzed American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Number Analyzed Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Number Analyzed Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Number Analyzed Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Number Analyzed Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Number Analyzed White | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 2 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 24 | 1 / 23 |
Outcome results
Primary
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
Population: Efficacy analysis performed on ITT and PP populations
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (15(±1) minutes post-challenge) | -0.366 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (20(±1) minutes post-challenge) | -0.206 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (7(±1) minutes post-challenge) | -0.171 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (7(±1) minutes post-challenge) | 0.162 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (20(±1) minutes post-challenge) | -0.491 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (15(±1) minutes post-challenge) | 0.039 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (15(±1) minutes post-challenge) | -0.208 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (20(±1) minutes post-challenge) | 0.002 score on a scale |
| VSJ-110 | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (7(±1) minutes post-challenge) | -0.280 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (20(±1) minutes post-challenge) | 0.035 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (7(±1) minutes post-challenge) | 0.075 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (15(±1) minutes post-challenge) | -0.108 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 16 hours (20(±1) minutes post-challenge) | -0.151 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (7(±1) minutes post-challenge) | -0.075 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (15(±1) minutes post-challenge) | -0.201 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 8 hours (20(±1) minutes post-challenge) | -0.203 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (7(±1) minutes post-challenge) | 0.252 score on a scale |
| Placebo | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | 15 minutes (15(±1) minutes post-challenge) | 0.030 score on a scale |
Primary
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
Population: Efficacy analysis performed on ITT and PP populations
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (5(±1) minutes post-challenge) | -0.424 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (7(±1) minutes post-challenge) | -0.698 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (3(±1) minutes post-challenge) | -0.383 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (3(±1) minutes post-challenge) | 0.039 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (7(±1) minutes post-challenge) | -0.450 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (5(±1) minutes post-challenge) | -0.248 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (5(±1) minutes post-challenge) | -0.593 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (7(±1) minutes post-challenge) | -0.422 score on a scale |
| VSJ-110 | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (3(±1) minutes post-challenge) | -0.228 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (7(±1) minutes post-challenge) | -0.314 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (3(±1) minutes post-challenge) | 0.010 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (5(±1) minutes post-challenge) | -0.035 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 16 hours (7(±1) minutes post-challenge) | -0.182 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (3(±1) minutes post-challenge) | -0.402 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (5(±1) minutes post-challenge) | -0.569 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 8 hours (7(±1) minutes post-challenge) | -0.772 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (3(±1) minutes post-challenge) | -0.007 score on a scale |
| Placebo | Ocular Itching as Measured by Self-reported Numerical Scales | 15 minutes (5(±1) minutes post-challenge) | -0.140 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 16 hours (rates across all three time points) | 3 Participants |
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 8 hours (rates across all three time points) | 1 Participants |
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 15 minutes (rates across all three time points) | 0 Participants |
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 16 hours (rates across two out of the three timepoints) | 5 Participants |
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 8 hours (rates across two out of the three timepoints) | 1 Participants |
| VSJ-110 | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 15 minutes (rates across two out of the three timepoints) | 0 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 8 hours (rates across two out of the three timepoints) | 0 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 16 hours (rates across all three time points) | 0 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 16 hours (rates across two out of the three timepoints) | 1 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 8 hours (rates across all three time points) | 0 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 15 minutes (rates across two out of the three timepoints) | 1 Participants |
| Placebo | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | 15 minutes (rates across all three time points) | 0 Participants |