Olopatadine Eye Drops and Allergy Skin Testing

Not Applicable

Completed

• Conditions: Allergic Rhinitis; Allergic Conjunctivitis
• Interventions: Drug: olopatadine; Drug: placebo

• Registration Number: NCT00775658
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Results First Submitted: 2017-02-21
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
olopatadine then placebo	olopatadine	participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
placebo then olopatadine	placebo	participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
olopatadine then placebo	placebo	participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
placebo then olopatadine	olopatadine	participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days

Primary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Vanderbilt Asthma, Sinus and Allergy Program Research; 🇺🇸 Nashville, Tennessee, United States