A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Not Applicable

Completed

• Conditions: Myopia; Refractive Error
• Interventions: Device: Lotrafilcon B contact lens with color; Device: Phemfilcon A contact lens with color

• Registration Number: NCT01782482
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study Start: 2013-02
• Study First Posted: 2013-02-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-02-18
• Results First Submitted QC: 2014-02-18
• Status Verified: 2014-03
• Results First Posted: 2014-03-28
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 574

Inclusion Criteria

• Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance.
• Manifest cylinder less than or equal to 0.75 diopter in each eye.
• Wear contact lenses within protocol-defined specifications.
• Require spherical contact lenses within the available range of powers.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Any eye condition that contraindicates contact lens wear.
• Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Moderate or severe ocular findings upon examination.
• Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops.
• Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
• Previous corneal or refractive surgery or irregular cornea.
• Eye injury or surgery within the last 6 months (excluding placement of punctal plugs).
• Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIR OPTIX® COLORS	Lotrafilcon B contact lens with color	Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
FRESHLOOK® COLORBLENDS	Phemfilcon A contact lens with color	Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.

Primary Outcome Measures

Name	Time	Method
Subjective Rating of Overall Satisfaction	Day 7	Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.

Secondary Outcome Measures

Name	Time	Method
Positive Purchase Intent	Day 7	As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase."