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Olopatadine Eye Drops and Allergy Skin Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Michael Fahrenholz, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00775658
First received: October 17, 2008
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

Condition Intervention
Allergic Rhinitis Allergic Conjunctivitis Drug: olopatadine Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 John Michael Fahrenholz, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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) ]
  • 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) ]

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 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
Drug: olopatadine
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
Drug: placebo
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
Active Comparator: 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
Drug: olopatadine
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
Drug: placebo
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 Medical Center
  More Information

Responsible Party: John Michael Fahrenholz, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00775658     History of Changes
Other Study ID Numbers: 071260
Study First Received: October 17, 2008
Results First Received: February 21, 2017
Last Updated: June 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Michael Fahrenholz, Vanderbilt University Medical Center:
allergy
skin testing
eye drops
antihistamines

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
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
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 22, 2017