Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

NCT ID: NCT00586625

Last Updated: 2013-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

861 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Detailed Description

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Conditions

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Allergic Conjunctivitis

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

One drop, both eyes, twice a day

Placebo

vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One drop, both eyes, twice a day

Interventions

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Bepreve

One drop, both eyes, twice a day

Intervention Type DRUG

Placebo

One drop, both eyes, twice a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria

* No active ocular disease
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Other Identifiers

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CL-SAF-0405071-P

Identifier Type: -

Identifier Source: org_study_id

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