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Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01174823
First received: August 2, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: bepotastine besilate ophthalmic solution
Drug: placebo comparator ophthalmic solution
 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: Pinkeye
Drug Information available for: Bepotastine
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Rhinoconjunctivitis quality of life questionnaire [ Time Frame: Day -7 to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepotastine Besilate Ophthalmic Solution Drug: bepotastine besilate ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: Placebo Drug: placebo comparator ophthalmic solution
sterile ophthalmic solution

  Eligibility

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

Inclusion Criteria:

  • Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

Exclusion Criteria:

  • No active ocular or nasal infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174823

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: NCT01174823     History of Changes
Other Study ID Numbers: S00041
Study First Received: August 2, 2010
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013