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Safety Study of Olopatadine Nasal Spray

This study has been completed.
Information provided by:
Alcon Research Identifier:
First received: December 19, 2007
Last updated: February 23, 2010
Last verified: February 2010
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.

Condition Intervention Phase
Perennial Allergic Rhinitis Drug: Olopatadine 0.6% nasal spray Drug: Placebo Nasal Spray Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety Study of Olopatadine Nasal Spray

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire [ Time Frame: day 30 ]
    Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.

Secondary Outcome Measures:
  • Average Number of Days of Rescue Medication Taken [ Time Frame: Month 1 through Month 12 ]

Enrollment: 890
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine 0.6% Nasal Spray
2 sprays each nostril twice daily
Drug: Olopatadine 0.6% nasal spray
2 sprays each nostril twice daily
Placebo Comparator: Placebo Nasal Spray
2 sprays each nostril twice daily
Drug: Placebo Nasal Spray
2 sprays each nostril twice daily


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria:

  • Age 11 years and younger
  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 identifier: NCT00578331

United States, Texas
Waco, Texas, United States, 76712
Sponsors and Collaborators
Alcon Research
Study Director: Margaret Drake Alcon Research
  More Information

Responsible Party: Margaret Drake, Alcon Identifier: NCT00578331     History of Changes
Other Study ID Numbers: C-05-69
Study First Received: December 19, 2007
Results First Received: July 7, 2009
Last Updated: February 23, 2010

Keywords provided by Alcon Research:
perennial allergic rhinitis
allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017