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

NCT ID: NCT01782482

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

Brief Summary

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

Conditions

Myopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

AIR OPTIX® COLORS

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.

Group Type: EXPERIMENTAL

Lotrafilcon B contact lens with color

Intervention Type: DEVICE

Silicone hydrogel contact lens with color

FRESHLOOK® COLORBLENDS

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.

Group Type: ACTIVE_COMPARATOR

Phemfilcon A contact lens with color

Intervention Type: DEVICE

Hydrogel contact lens with color

Interventions

Lotrafilcon B contact lens with color

Silicone hydrogel contact lens with color

Intervention Type: DEVICE

Phemfilcon A contact lens with color

Hydrogel contact lens with color

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® COLORS; FRESHLOOK® COLORBLENDS

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Holden Thomas, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-003

Identifier Type: -

Identifier Source: org_study_id