Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

NCT ID: NCT00223951

Last Updated: 2015-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

Detailed Description

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Conditions

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Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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R89674 (generic name not yet established)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better

\-

Exclusion Criteria

intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vistakon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jack V Greiner, OD, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Associates, North Andover, MA

Locations

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Phoenix, Arizona, United States

Site Status

Bel Air, Maryland, United States

Site Status

North Andover, Massachusetts, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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05-003-10

Identifier Type: -

Identifier Source: org_study_id

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