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

Alcon

Status: Completed

Conditions: Contact Lenses

Treatments: Device: Opti-Free RepleniSH multi-purpose disinfecting solution; Device: Comfilcon A contact lens (Biofinity); Device: Clear Care cleaning and disinfecting system; Device: Senofilcon A contact lens (ACUVUE OASYS); Device: Lotrafilcon B contact lens (AIR OPTIX AQUA); Device: ReNu MultiPlus multi-purpose solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982046

M-09-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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75 participants in 3 patient groups

ACUVUE OASYS

Active Comparator group

Description:

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.

Treatment:

Device: ReNu MultiPlus multi-purpose solution

Device: Senofilcon A contact lens (ACUVUE OASYS)

Device: Clear Care cleaning and disinfecting system

Device: Opti-Free RepleniSH multi-purpose disinfecting solution

AIR OPTIX AQUA

Active Comparator group

Description:

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.

Treatment:

Device: ReNu MultiPlus multi-purpose solution

Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)

Device: Clear Care cleaning and disinfecting system

Device: Opti-Free RepleniSH multi-purpose disinfecting solution

Biofinity

Active Comparator group

Description:

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.

Treatment:

Device: ReNu MultiPlus multi-purpose solution

Device: Clear Care cleaning and disinfecting system

Device: Comfilcon A contact lens (Biofinity)

Device: Opti-Free RepleniSH multi-purpose disinfecting solution