Olopatadine Eye Drops and Allergy Skin Testing

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775658
• Other study ID #: 071260
• Status: Completed
• Phase: N/A
• First received: October 17, 2008
• Last updated: October 17, 2008
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: October 2008
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• olopatadine 0.2% opthalmic solution

• placebo, normal saline opthalmic solution

Locations

Country	Name	City	State
United States	Vanderbilt Asthma, Sinus and Allergy Program Research	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in area (mm2) of the wheal and flare histamine skin test response during treatment with olopatadine compared to placebo.		primary outcome measure assessed at baseline, study visit day >5 and study visit day >17.	No