Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01398787
First received: July 19, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention
Cosmetic Appearance
Device: Lotrafilcon B contact lens with color
Device: Phemfilcon A contact lens with color

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Preference [ Time Frame: Day 1, 2-10 minutes after lens insertion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 198
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: FRESHLOOK® COLORBLENDS

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398787

Sponsors and Collaborators
CIBA VISION
Investigators
Study Director: Sharon Holden Thomas, O.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01398787     History of Changes
Other Study ID Numbers: P-383-C-004
Study First Received: July 19, 2011
Results First Received: February 18, 2014
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014