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Safety and Efficacy of Bepotastine in the Treatment of Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01277341
First received: January 7, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Bepotastine besilate proprietary formulation
Drug: Placebo comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
Drug Information available for: Bepotastine
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Total nasal symptom score [ Time Frame: Day -10 to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm No. 1 Drug: Bepotastine besilate proprietary formulation
nasal spray
Experimental: Arm No. 2 Drug: Bepotastine besilate proprietary formulation
nasal spray
Experimental: Arm No. 3 Drug: Bepotastine besilate proprietary formulation
nasal spray
Placebo Comparator: Arm No. 4 Drug: Placebo comparator
nasal spray

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria:

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277341

Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01277341     History of Changes
Other Study ID Numbers: S00082
Study First Received: January 7, 2011
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
 Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 17, 2013