Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01398787
• Collaborator: (none)
• Enrollment: 198
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cosmetic Appearance	Device: Lotrafilcon B contact lens with color; Device: Phemfilcon A contact lens with color	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Official Title: Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIR OPTIX® COLORS 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	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; Other Names: AIR OPTIX® COLORS
Active Comparator: FRESHLOOK® COLORBLENDS 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	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; Other Names: FRESHLOOK® COLORBLENDS

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

• Study Director: Sharon Holden Thomas, O.D., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01398787
• Other Study ID Numbers: P-383-C-004
• First Posted: Jul 21, 2011
• Last Update Posted: Mar 28, 2014
• Last Verified: Feb 1, 2014

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 18 US study centers.
Pre-assignment Detail	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).

Arm/Group Title	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS
Arm/Group Description	AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
Period Title: Overall Study
STARTED	198
COMPLETED	197
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS
Arm/Group Description	AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
Overall Participants	197
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.9 (12.9)
Sex: Female, Male (Count of Participants)
Female	174 88.3%
Male	23 11.7%

Outcome Measures

1. Primary Outcome

Title	Overall Preference
Description	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).
Time Frame	Day 1, 2-10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
Number [Percentage of participants]	49.1 24.9%	24.6 NaN

2. Primary Outcome

Title	Initial Comfort Preference
Description	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).
Time Frame	Day 1, 2 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
Number [Percentage of participants]	55.1 28%	23.4 NaN

3. Primary Outcome

Title	Appearance Preference
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
Number [Percentage of participants]	36.5 18.5%	23.4 NaN

4. Primary Outcome

Title	Subjective Rating of Initial Comfort
Description	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).
Time Frame	Day 1, 2 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
Mean (Standard Deviation) [Units on a scale]	8.6 (1.9)	7.5 (2.5)

5. Primary Outcome

Title	Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)
Description	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).
Time Frame	Day 1, 2-10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
The lens looks natural on my eye	84.9 43.1%	77.0 NaN
The lens makes my eye look bold	78.9 40.1%	81.3 NaN
The lens makes my eye look bright	81.3 41.3%	75.8 NaN
The lens makes my eye look beautiful	89.1 45.2%	84.9 NaN
The lens makes my eye noticeable	93.9 47.7%	94.0 NaN
The lens enhances my eye color	81.9 41.6%	78.8 NaN
I like the way my eye looks	89.1 45.2%	84.8 NaN
The lens makes me look beautiful	84.9 43.1%	83.1 NaN
The lens transforms the color of my eye	88.6 45%	93.4 NaN

6. Primary Outcome

Title	Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)
Description	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).
Time Frame	Day 1, 2-10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AIR OPTIX® COLORS	FRESHLOOK® COLORBLENDS
Arm/Group Description	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	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
Measure Participants	168	168
Number [Percentage of participants]	80.2 40.7%	59.9 NaN

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (5 months). An AE was defined as any untoward device experience with investigational or marketed product, whether it was considered to be device related or not.
Adverse Event Reporting Description	The analysis population includes all enrolled and exposed participants.
Arm/Group Title	AIR OPTIX® COLORS		FRESHLOOK® COLORBLENDS
Arm/Group Description	Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each		Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
All Cause Mortality
	AIR OPTIX® COLORS		FRESHLOOK® COLORBLENDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AIR OPTIX® COLORS		FRESHLOOK® COLORBLENDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/197 (0%)
Other (Not Including Serious) Adverse Events
	AIR OPTIX® COLORS		FRESHLOOK® COLORBLENDS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/197 (0%)		0/197 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.