Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
NCT ID: NCT00586664
Last Updated: 2013-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2007-10-31
2008-06-30
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
TRIPLE
Study Groups
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Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
Bepreve (bepotastine besilate ophthalmic solution) 1.5%
sterile ophthalmic solution
Bepotastine Besilate Ophthalmic Solution 1.0%
Bepotastine Besilate Ophthalmic Solution 1.0%
sterile ophthalmic solution
Placebo
placebo comparator
sterile ophthalmic solution
Interventions
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Bepreve (bepotastine besilate ophthalmic solution) 1.5%
sterile ophthalmic solution
placebo comparator
sterile ophthalmic solution
Bepotastine Besilate Ophthalmic Solution 1.0%
sterile ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Tim McNamara, PharmD
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.
Macejko TT, Bergmann MT, Williams JI, Gow JA, Gomes PJ, McNamara TR, Abelson MB; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis. Am J Ophthalmol. 2010 Jul;150(1):122-127.e5. doi: 10.1016/j.ajo.2010.02.007. Epub 2010 May 20.
Other Identifiers
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CL-S&E-0409071-P
Identifier Type: -
Identifier Source: org_study_id
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