Trial Outcomes & Findings for Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS (NCT NCT01398787)

NCT ID: NCT01398787

Last Updated: 2014-03-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

198 participants

Primary outcome timeframe

Day 1, 2-10 minutes after lens insertion

Results posted on

2014-03-28

Participant Flow

Participants were recruited from 18 US study centers.

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).

Participant milestones

Participant milestones
Measure	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
Overall Study STARTED	198
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS n=197 Participants AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
Age, Continuous	33.9 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, 2-10 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Overall Preference	49.1 Percentage of participants	24.6 Percentage of participants

PRIMARY outcome

Timeframe: Day 1, 2 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Initial Comfort Preference	55.1 Percentage of participants	23.4 Percentage of participants

PRIMARY outcome

Timeframe: Day 1, 2-10 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Appearance Preference	36.5 Percentage of participants	23.4 Percentage of participants

PRIMARY outcome

Timeframe: Day 1, 2 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Subjective Rating of Initial Comfort	8.6 Units on a scale Standard Deviation 1.9	7.5 Units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Day 1, 2-10 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens looks natural on my eye	84.9 Percentage of participants	77.0 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens makes my eye look bold	78.9 Percentage of participants	81.3 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens makes my eye look bright	81.3 Percentage of participants	75.8 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens makes my eye look beautiful	89.1 Percentage of participants	84.9 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens makes my eye noticeable	93.9 Percentage of participants	94.0 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens enhances my eye color	81.9 Percentage of participants	78.8 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) I like the way my eye looks	89.1 Percentage of participants	84.8 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens makes me look beautiful	84.9 Percentage of participants	83.1 Percentage of participants
Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) The lens transforms the color of my eye	88.6 Percentage of participants	93.4 Percentage of participants

PRIMARY outcome

Timeframe: Day 1, 2-10 minutes after lens insertion

Population: The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.

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).

Outcome measures

Outcome measures
Measure	AIR OPTIX® COLORS n=168 Participants Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes	FRESHLOOK® COLORBLENDS n=168 Participants Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)	80.2 Percentage of participants	59.9 Percentage of participants

Adverse Events

AIR OPTIX® COLORS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FRESHLOOK® COLORBLENDS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharon Holden Thomas, Sr. Principal Clinical Scientist

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER