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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Ophthalmic Solutions
Pharmaceutical Solutions
Olopatadine
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists

ClinicalTrials.gov processed this record on August 28, 2014