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Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

NCT ID: NCT01211535

Last Updated: 2012-11-12

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

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

Detailed Description

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Conditions

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Myopia Astigmatism Refractive Error

Keywords

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Soft contact lenses Multi-purpose Solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OPTI-FREE RepleniSH

OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Group Type EXPERIMENTAL

OPTI-FREE RepleniSH multipurpose solution

Intervention Type DEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

Silicone hydrogel contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

ReNu Biotrue

ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Group Type ACTIVE_COMPARATOR

ReNu Biotrue multipurpose solution

Intervention Type DEVICE

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Silicone hydrogel contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Interventions

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OPTI-FREE RepleniSH multipurpose solution

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

Intervention Type DEVICE

ReNu Biotrue multipurpose solution

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Intervention Type DEVICE

Silicone hydrogel contact lenses

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Intervention Type DEVICE

Other Intervention Names

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OPTI-FREE® RepleniSH® ReNu Biotrue™

Eligibility Criteria

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Inclusion Criteria

* Currently wearing silicone hydrogel contact lenses on a daily wear basis;
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Generally healthy;
* Normal ocular health;
* Willing to follow study procedures and visit schedule;
* Sign Informed Consent and privacy document;

Exclusion Criteria

* Use of additional lens cleaners;
* Known sensitivities to any ingredient in either test article;
* Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
* History of ocular surgery/trauma within the last 6 months;
* Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
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

Locations

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Contact Alcon Trial Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-09-59

Identifier Type: -

Identifier Source: org_study_id