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Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration

NCT ID: NCT00659815

Last Updated: 2011-12-12

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

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

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The objective of the study is to evaluate the product performance of Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration

Detailed Description

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Conditions

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Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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ReNu in Currently Marketed Bottle

Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.

Group Type ACTIVE_COMPARATOR

Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.

Intervention Type DEVICE

Daily care for contact lenses.

ReNu in Clear Resin Bottle

Bausch \& Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.

Group Type EXPERIMENTAL

Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.

Intervention Type DEVICE

Daily care for contact lenses

Interventions

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Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.

Daily care for contact lenses.

Intervention Type DEVICE

Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.

Daily care for contact lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is a habitual wearer of planned replacement soft contact lenses
* VA correctable to 0.3 LogMar or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

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
Minimum Eligible Age

18 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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Gerard Cairns, PhD, MCOptom

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

James Ferrari, OD

Role: PRINCIPAL_INVESTIGATOR

James Ferrari, OD

Locations

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James Ferrari, OD

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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549

Identifier Type: -

Identifier Source: org_study_id