Evaluation of the Cosmetic Performance… | Clinical Trial

Key information

Conditions

Cosmetic Appearance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lens with color

Device

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

Other names: AIR OPTIX® COLORS

Phemfilcon A contact lens with color

Device

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

Primary outcomes

Overall Preference

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jul 21, 2011
Registry last updated: Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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