A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

NCT ID: NCT01635933

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-09-30

Brief Summary

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 .

Conditions

Myopia

Study Design

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

Study Groups

AIR OPTIX® COLORS

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.

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 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.

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

• 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).

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.

• 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-12-005

Identifier Type: -

Identifier Source: org_study_id