A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Phemfilcon A contact lens with color; Device: Lotrafilcon B contact lens with color

Study type: Interventional

Funder types: Industry

Identifiers

NCT01635933

C-12-005

Details and patient eligibility

About

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

Enrollment: 370 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
• Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
• Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
• Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
• History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
• Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
• Monovision, monocular (only one eye with functional vision) or fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
• Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
• Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
• Participation in any investigational clinical study within previous 30 days.
• Other protocol-defined exclusion criteria may apply.

Trial design

370 participants in 2 patient groups

AIR OPTIX® COLORS

Experimental group

Description:

Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Treatment:

Device: Lotrafilcon B contact lens with color

FRESHLOOK® COLORBLENDS

Active Comparator group

Description:

Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Treatment:

Device: Phemfilcon A contact lens with color