A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

NCT ID: NCT00982046

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.

Detailed Description

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This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.

Conditions

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Contact Lenses

Keywords

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contact lenses disinfection solutions contact lens care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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ACUVUE OASYS

Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.

Group Type ACTIVE_COMPARATOR

Opti-Free RepleniSH multi-purpose disinfecting solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

ReNu MultiPlus multi-purpose solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

Clear Care cleaning and disinfecting system

Intervention Type DEVICE

Contact lens care system CE-marked for intended use.

Senofilcon A contact lens (ACUVUE OASYS)

Intervention Type DEVICE

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

AIR OPTIX AQUA

Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.

Group Type ACTIVE_COMPARATOR

Opti-Free RepleniSH multi-purpose disinfecting solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

ReNu MultiPlus multi-purpose solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

Clear Care cleaning and disinfecting system

Intervention Type DEVICE

Contact lens care system CE-marked for intended use.

Lotrafilcon B contact lens (AIR OPTIX AQUA)

Intervention Type DEVICE

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

Biofinity

Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.

Group Type ACTIVE_COMPARATOR

Opti-Free RepleniSH multi-purpose disinfecting solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

ReNu MultiPlus multi-purpose solution

Intervention Type DEVICE

Contact lens solution CE-marked for intended use.

Clear Care cleaning and disinfecting system

Intervention Type DEVICE

Contact lens care system CE-marked for intended use.

Comfilcon A contact lens (Biofinity)

Intervention Type DEVICE

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

Interventions

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Opti-Free RepleniSH multi-purpose disinfecting solution

Contact lens solution CE-marked for intended use.

Intervention Type DEVICE

ReNu MultiPlus multi-purpose solution

Contact lens solution CE-marked for intended use.

Intervention Type DEVICE

Clear Care cleaning and disinfecting system

Contact lens care system CE-marked for intended use.

Intervention Type DEVICE

Senofilcon A contact lens (ACUVUE OASYS)

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

Intervention Type DEVICE

Lotrafilcon B contact lens (AIR OPTIX AQUA)

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

Intervention Type DEVICE

Comfilcon A contact lens (Biofinity)

Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.

Intervention Type DEVICE

Other Intervention Names

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Opti-Free® RepleniSH® ReNu® MultiPlus® Clear Care® ACUVUE® OASYS™ AIR OPTIX® AQUA Biofinity®

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* Adapted contact lens wearer for at least one month.
* Spherical prescription range between +6.00 to -8.00 diopters.
* Astigmatism of less than or equal to 1.00 diopter in at least one eye.
* Normal eyes with no evidence of abnormality or disease.

Exclusion Criteria

* Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
* Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
* Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
* Eye injury or surgery within 8 weeks prior to study.
* Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
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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Visioncare Research Ltd.

Farnham, Surrey, United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.

Reference Type RESULT

Other Identifiers

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M-09-05

Identifier Type: -

Identifier Source: org_study_id