Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

NCT ID: NCT01398787

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.

Detailed Description

In this non-dispensing trial, each participant wore 4 pairs of color contact lenses (gray, blue, green, hazel) sequentially for less than 10 minutes each in a contralateral fashion (test lens in one eye, control lens in the other eye). Randomization took place for each of the 4 pairs of lenses as to which eye (left or right) wore the test and which wore the control. Participants were selected based on eye color (dark vs light/medium). The primary analysis population (AP1) was pre-specified as participants of any eye color who habitually wore FRESHLOOK® COLORBLENDS lenses in one of the four colors tested in this trial. Pair 1 lenses were dispensed per the participant's habitual lens color.

Conditions

Cosmetic Appearance

Study Design

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

Study Groups

AIR OPTIX® COLORS

Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear

Group Type: EXPERIMENTAL

Lotrafilcon B contact lens with color

Intervention Type: DEVICE

Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel

FRESHLOOK® COLORBLENDS

Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear

Group Type: ACTIVE_COMPARATOR

Phemfilcon A contact lens with color

Intervention Type: DEVICE

Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel

Interventions

Lotrafilcon B contact lens with color

Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel

Intervention Type: DEVICE

Phemfilcon A contact lens with color

Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® COLORS; FRESHLOOK® COLORBLENDS

Eligibility Criteria

Inclusion Criteria

• Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
• Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses.
• Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week.

Exclusion Criteria

• Eye injury or surgery within twelve weeks of enrollment in this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systematic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CIBA VISION

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Holden Thomas, O.D.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

P-383-C-004

Identifier Type: -

Identifier Source: org_study_id