A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Alcon

Status: Completed

Conditions: Myopia; Refractive Error

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01782482

C-12-003

Details and patient eligibility

About

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Enrollment: 574 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
• Manifest cylinder less than or equal to 0.75 diopter in each eye.
• Wear contact lenses within protocol-defined specifications.
• Require spherical contact lenses within the available range of powers.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any eye condition that contraindicates contact lens wear.
• Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Moderate or severe ocular findings upon examination.
• Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
• Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
• Previous corneal or refractive surgery or irregular cornea.
• Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
• Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• Other protocol-defined exclusion criteria may apply.

Trial design

574 participants in 2 patient groups

AIR OPTIX® COLORS

Experimental group

Description:

Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. 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 on a daily wear basis for 7 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