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: December 4, 2013
Last verified: December 2013
  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:


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
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: 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: December 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 19, 2014