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Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

NCT ID: NCT01494818

Last Updated: 2013-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

Detailed Description

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The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Conditions

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Contact Lens Care

Keywords

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Contact lenses Contact lens solutions

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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CLEAR CARE/AOSEPT Plus

Hydrogen peroxide-based contact lens care system used per manufacturer's instructions

Group Type EXPERIMENTAL

Hydrogen peroxide-based contact lens care system

Intervention Type DEVICE

Soft contact lenses

Intervention Type DEVICE

Contact lenses identical to habitual prescription worn per usual replacement regimen

ReNu MultiPlus

PHMB-containing contact lens solution used per manufacturer's instructions

Group Type ACTIVE_COMPARATOR

PHMB-containing contact lens solution

Intervention Type DEVICE

Soft contact lenses

Intervention Type DEVICE

Contact lenses identical to habitual prescription worn per usual replacement regimen

Interventions

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Hydrogen peroxide-based contact lens care system

Intervention Type DEVICE

PHMB-containing contact lens solution

Intervention Type DEVICE

Soft contact lenses

Contact lenses identical to habitual prescription worn per usual replacement regimen

Intervention Type DEVICE

Other Intervention Names

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CLEAR CARE®/AOSEPT Plus ReNu® MultiPlus Multi-Purpose solution

Eligibility Criteria

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Inclusion Criteria

* Read and understand Participant Information Sheet;
* Read, sign, and date Informed Consent;
* Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality;
* Using a PHMB-containing multipurpose contact lens solution;
* Symptomatic, as specified in protocol;
* Best corrected visual acuity of 6/9 or better in each eye;

Exclusion Criteria

* Any known sensitivity or intolerance to the contact lenses or len care products to be used;
* Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects;
* Ocular allergies or ocular disease which might interfere with contact lens wear;
* Use of any concomitant topical ocular medications during the study period;
* Participation in an investigational drug or device study within 30 days of entering the study;
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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Michel Guillon, PhD, FCOptom, FAAO, CCTI

Role: PRINCIPAL_INVESTIGATOR

OTG Research & Consultancy

Countries

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United States

Other Identifiers

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ID 10-59 / M-11-02

Identifier Type: -

Identifier Source: org_study_id