Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

Ciba Vision

Status: Completed

Conditions: Cosmetic Appearance

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398787

P-383-C-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Trial design

198 participants in 2 patient groups

AIR OPTIX® COLORS

Experimental group

Description:

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

Treatment:

Device: Lotrafilcon B contact lens with color

FRESHLOOK® COLORBLENDS

Active Comparator group

Description:

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

Treatment:

Device: Phemfilcon A contact lens with color