Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA); Device: Contact lens solution (Clear Care®); Device: Balafilcon A contact lens (PureVision® 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01300767

P-336-C-019

Details and patient eligibility

About

The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
• Willing and able to wear spherical contact lenses within the available range of powers.
• Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Astigmatism of 1.00D or more.
• Currently wearing contact lenses in a daily disposable modality.
• Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
• Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Lotrafilcon B

Experimental group

Description:

Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.

Treatment:

Device: Contact lens solution (Clear Care®)

Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)

Balafilcon A

Active Comparator group

Description:

Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.

Treatment:

Device: Balafilcon A contact lens (PureVision® 2)

Device: Contact lens solution (Clear Care®)