Allergic Rhinitis, Allergic Conjunctivitis
Conditions
Keywords
allergy, skin testing, eye drops, antihistamines
Brief summary
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.
Interventions
DRUGolopatadine
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
DRUGplacebo
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 75 years * Healthy volunteers (no major illnesses or active symptoms)
Exclusion criteria
* Known allergy or hypersensitivity to the drugs or components * Pregnant or nursing women * Women wishing to become pregnant during the study's duration * Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization * Dermatographism as evidenced on skin testing on visit 1 * Chronic urticaria active within the past 6 months * Severe hypertension * Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | at baseline and at return visit (between study day 7-10) |
| The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | at baseline and at return visit (between study day 7-10) |
Countries
United States
Participant flow
Pre-assignment details
Three participants withdrew prior to any study procedure: 1 had and upper respiratory infection, 1 required use of oral anti histamine and 1 was lost to follow up
Participants by arm
| Arm | Count |
|---|---|
| All Participants Includes both groups of participants | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time frame: at baseline and at return visit (between study day 7-10)
Population: Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine | The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | 6.95 cm2 | Standard Deviation 4.68 |
| Placebo | The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | 8.31 cm2 | Standard Deviation 3.98 |
p-value: 0.09Wilcoxon (Mann-Whitney)
Primary
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time frame: at baseline and at return visit (between study day 7-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine | The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | 0.461 cm2 | Standard Deviation 0.279 |
| Placebo | The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. | 0.464 cm2 | Standard Deviation 0.254 |
Comparison: Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.p-value: 0.57Wilcoxon (Mann-Whitney)