NCT01398787

Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: CIBA VISION · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Lotrafilcon B contact lens with color	Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel
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

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-07-21
• Last updated: 2014-03-28
• Results posted: 2014-03-28