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Olopatadine Eye Drops and Allergy Skin Testing

Primary Purpose

Allergic Rhinitis, Allergic Conjunctivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
olopatadine
placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Rhinitis focused on measuring allergy, skin testing, eye drops, antihistamines

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt Asthma, Sinus and Allergy Program Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

olopatadine then placebo

placebo then olopatadine

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2008
Last Updated
June 12, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00775658
Brief Title
Olopatadine Eye Drops and Allergy Skin Testing
Official Title
Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Conjunctivitis
Keywords
allergy, skin testing, eye drops, antihistamines

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olopatadine then placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo then olopatadine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
olopatadine
Intervention Description
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
Primary Outcome Measure Information:
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Vanderbilt Asthma, Sinus and Allergy Program Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Olopatadine Eye Drops and Allergy Skin Testing

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