Clinical trial NCT01398787: Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
Official title: Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetic Appearance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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.
* 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.

Primary outcomes:
measure: Overall Preference
timeFrame: Day 1, 2-10 minutes after lens insertion
measure: Initial Comfort Preference
timeFrame: Day 1, 2 minutes after lens insertion
measure: Appearance Preference
timeFrame: Day 1, 2-10 minutes after lens insertion
measure: Subjective Rating of Initial Comfort
timeFrame: Day 1, 2 minutes after lens insertion
measure: Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)
timeFrame: Day 1, 2-10 minutes after lens insertion
measure: Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)
timeFrame: Day 1, 2-10 minutes after lens insertion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sharon Holden Thomas, O.D.
role: STUDY_DIRECTOR
References: