Olopatadine Eye Drops and Allergy Skin Testing

NCT ID: NCT00775658

Last Updated: 2017-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Allergic Rhinitis Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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olopatadine then 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

Group Type ACTIVE_COMPARATOR

olopatadine

Intervention Type DRUG

olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day

placebo

Intervention Type DRUG

placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

placebo then 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

Group Type ACTIVE_COMPARATOR

olopatadine

Intervention Type DRUG

olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day

placebo

Intervention Type DRUG

placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

Interventions

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olopatadine

olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day

Intervention Type DRUG

placebo

placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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John Michael Fahrenholz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt Asthma, Sinus and Allergy Program Research

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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071260

Identifier Type: -

Identifier Source: org_study_id

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