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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis

Detailed Description

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Conditions

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Conjunctivitis, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bepreve

Bepotastine Besilate Ophthalmic Solution 1.5%

Group Type EXPERIMENTAL

Bepreve

Intervention Type DRUG

sterile ophthalmic solution

Placebo

sterile ophthalmic solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sterile ophthalmic solution

Bepotastine Besilate

sterile ophthalmic solution 1.0%

Group Type EXPERIMENTAL

Bepotastine Besilate

Intervention Type DRUG

sterile ophthalmic solution

Interventions

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Bepreve

sterile ophthalmic solution

Intervention Type DRUG

Placebo

sterile ophthalmic solution

Intervention Type DRUG

Bepotastine Besilate

sterile ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 10 years of age \& either sex, any race
* Willing and able to follow all instructions and attend all study visits
* Positive history of ocular allergies

Exclusion Criteria

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy, or lactating
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 22991696 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20642205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19843481 (View on PubMed)

Other Identifiers

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ISTA-BEPO-CS01

Identifier Type: -

Identifier Source: org_study_id

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