Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398787

Enrollment

198

Registered

2011-07-21

Start date

2011-07-31

Completion date

2011-12-31

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmetic Appearance

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.

Interventions

DEVICELotrafilcon B contact lens with color

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

DEVICEPhemfilcon 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Preference	Day 1, 2-10 minutes after lens insertion	The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Initial Comfort Preference	Day 1, 2 minutes after lens insertion	The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Appearance Preference	Day 1, 2-10 minutes after lens insertion	The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Subjective Rating of Initial Comfort	Day 1, 2 minutes after lens insertion	The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)	Day 1, 2-10 minutes after lens insertion	The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).
Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)	Day 1, 2-10 minutes after lens insertion	The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).

Participant flow

Recruitment details

Participants were recruited from 18 US study centers.

Pre-assignment details

Of the 198 enrolled participants, 1 was exited as a screen failure prior to study product exposure. This reporting group includes all enrolled and exposed participants (197).

Participants by arm

Arm	Count
AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear	197
Total	197

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1

Baseline characteristics

Characteristic	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS
Age, Continuous	33.9 years STANDARD_DEVIATION 12.9
Sex: Female, Male Female	174 Participants
Sex: Female, Male Male	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 197	0 / 197
serious Total, serious adverse events	0 / 197	0 / 197

Outcome results

Primary

Appearance Preference

The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).

Time frame: Day 1, 2-10 minutes after lens insertion