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Evaluation of a Multi-Purpose Solution

NCT ID: NCT00710879

Last Updated: 2011-12-13

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

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

Detailed Description

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Conditions

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Contact Lens Solutions

Keywords

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Efficacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Multipurpose Solution

Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.

Group Type EXPERIMENTAL

Bausch & Lomb Multi-Purpose Solution

Intervention Type DEVICE

Daily care for contact lenses.

Interventions

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Bausch & Lomb Multi-Purpose Solution

Daily care for contact lenses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
* Must be able and willing to comply with all treatment and follow-up study procedures.
* Must have a clear central cornea.
* VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria

* Systemic disease affecting ocular health.
* Using systemic or topical medications.
* Wear monovision, multifocal or toric contact lenses.
* Any grade 2 or greater slit lamp findings.
* Pregnancy
Minimum Eligible Age

18 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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Bev Barna

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Dr. Nicholas Marsico

Torrance, California, United States

Site Status

Countries

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United States

Other Identifiers

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568

Identifier Type: -

Identifier Source: org_study_id