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N/A N=21 Randomized Double-blind Diagnostic

Olopatadine Eye Drops and Allergy Skin Testing

Allergic Rhinitis · Allergic Conjunctivitis

Enrolled (actual)
21
Serious AEs
Results posted
Jul 2017
Primary outcome: Primary: The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. — 0.461; 0.464 cm2 — p=0.57

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
olopatadine (Drug); placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Jun 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
0.461; 0.464 0.57
PRIMARY
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
6.95; 8.31 0.09

Summary

Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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