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Olopatadine Eye Drops and Allergy Skin Testing

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00775658
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention
Allergic Rhinitis
Allergic Conjunctivitis
 Drug: olopatadine 0.2% opthalmic solution
Drug: placebo, normal saline opthalmic solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline

Resource links provided by NLM:

MedlinePlus related topics: Allergy Pinkeye
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • The difference in area (mm2) of the wheal and flare histamine skin test response during treatment with olopatadine compared to placebo. [ Time Frame: primary outcome measure assessed at baseline, study visit day >5 and study visit day >17. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: olopatadine 0.2% opthalmic solution Drug: olopatadine 0.2% opthalmic solution
Placebo Comparator: placebo, normal saline opthalmic solution Drug: placebo, normal saline opthalmic solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775658

Locations
United States, Tennessee
Vanderbilt Asthma, Sinus and Allergy Program Research
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: John Fahrenholz, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00775658     History of Changes
Other Study ID Numbers: 071260
Study First Received: October 17, 2008
Last Updated: October 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
allergy
skin testing
eye drops
antihistamines

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
 Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013