Olopatadine Eye Drops and Allergy Skin Testing

Condition(s) targeted: Allergic Rhinitis; Allergic Conjunctivitis

Intervention: olopatadine 0.2% opthalmic solution (Drug); placebo, normal saline opthalmic solution (Drug)

Phase: N/A

Status: Completed

Sponsored by: Vanderbilt University

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

Official title: Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome: The difference in area (mm2) of the wheal and flare histamine skin test response during treatment with olopatadine compared to placebo.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Vanderbilt Asthma, Sinus and Allergy Program Research, Nashville, Tennessee 37203, United States

Starting date: January 2008
Last updated: October 17, 2008