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

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

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lens with color; Device: Phemfilcon A contact lens with color

• Study Type: Interventional
• Enrollment (Actual): 574
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIR OPTIX® COLORS; 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.	Device: Lotrafilcon B contact lens with color; Silicone hydrogel contact lens with color; Other Names: AIR OPTIX® COLORS
Active Comparator: FRESHLOOK® COLORBLENDS; 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.	Device: Phemfilcon A contact lens with color; Hydrogel contact lens with color; Other Names: FRESHLOOK® COLORBLENDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Rating of Overall Satisfaction	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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Purchase Intent	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."	Day 7

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Myopia; Refractive error; Color contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C-12-003