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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01174823
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: bepotastine besilate ophthalmic solution Drug: placebo comparator ophthalmic solution Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2010
Primary Completion Date : October 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
Drug Information available for: Bepotastine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bepotastine Besilate Ophthalmic Solution Drug: bepotastine besilate ophthalmic solution
sterile ophthalmic solution
Placebo Comparator: Placebo Drug: placebo comparator ophthalmic solution
sterile ophthalmic solution


Outcome Measures

Primary Outcome Measures :
  1. Rhinoconjunctivitis quality of life questionnaire [ Time Frame: Day -7 to Day 14 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

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