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: December 4, 2013
Last verified: December 2013
  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:


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 by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 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 April 17, 2014