Effect of an Investigational Multi-Purpose Solution on Lens Moisture

NCT ID: NCT01341990

Last Updated: 2012-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

Detailed Description

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Conditions

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Contact Lens Moisture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FID 114675A

Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses

Group Type EXPERIMENTAL

FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Intervention Type DEVICE

Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses

Silicone Hydrogel Contact Lenses

Intervention Type DEVICE

Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).

ReNu MultiPlus

Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses

Group Type ACTIVE_COMPARATOR

ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)

Intervention Type DEVICE

Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses

Silicone Hydrogel Contact Lenses

Intervention Type DEVICE

Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).

Interventions

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FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses

Intervention Type DEVICE

ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)

Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses

Intervention Type DEVICE

Silicone Hydrogel Contact Lenses

Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).

Intervention Type DEVICE

Other Intervention Names

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ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™ Acuvue® Oasys™ PureVision®

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
* Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
* Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.

Exclusion Criteria

* Known sensitivity or intolerance to contact lens multi-purpose solutions.
* Use of any topical ocular OTC or prescribed topical ocular medications.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Medical condition or use of medication that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin R Webb, OD

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-09-031

Identifier Type: -

Identifier Source: org_study_id

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