Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
NCT ID: NCT00424398
Last Updated: 2013-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
107 participants
INTERVENTIONAL
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bepreve
Bepotastine Besilate Ophthalmic Solution 1.5%
Bepreve
sterile ophthalmic solution
Placebo
sterile ophthalmic solution
Placebo
sterile ophthalmic solution
Bepotastine Besilate
sterile ophthalmic solution 1.0%
Bepotastine Besilate
sterile ophthalmic solution
Interventions
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Bepreve
sterile ophthalmic solution
Placebo
sterile ophthalmic solution
Bepotastine Besilate
sterile ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
* Willing and able to follow all instructions and attend all study visits
* Positive history of ocular allergies
Exclusion Criteria
* Female currently pregnant, planning a pregnancy, or lactating
10 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jon Williams, PhD
Role: STUDY_DIRECTOR
ISTA Pharmaceuticals, Inc.
Locations
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ISTA Pharmaceuticals, Inc.
Irvine, California, United States
Countries
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References
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Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012 May-Jun;33(3):265-74. doi: 10.2500/aap.2012.33.3570.
Torkildsen GL, Williams JI, Gow JA, Gomes PJ, Abelson MB, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution for the relief of nonocular symptoms provoked by conjunctival allergen challenge. Ann Allergy Asthma Immunol. 2010 Jul;105(1):57-64. doi: 10.1016/j.anai.2010.04.005.
Abelson MB, Torkildsen GL, Williams JI, Gow JA, Gomes PJ, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: a phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther. 2009 Sep;31(9):1908-21. doi: 10.1016/j.clinthera.2009.09.001.
Other Identifiers
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ISTA-BEPO-CS01
Identifier Type: -
Identifier Source: org_study_id
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