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

The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lenses with color printing; Device: Phemfilcon A contact lenses with color printing

• Study Type: Interventional
• Enrollment (Actual): 151
• 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 to sign an Informed Consent Document or Assent, if applicable.
• Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
• Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
• Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
• Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
• Interested in wearing contact lenses that change the appearance of the color of the eyes.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
• History of herpetic keratitis.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
• Corneal vascularization greater than 1 millimeter (mm) of penetration.
• 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.
• Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
• Anisometropia ≥1.50D (study contact lens prescription).
• History of intolerance or hypersensitivity to any component of the test articles.
• Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
• Participation in any clinical study within 30 days of Visit 1.
• Other protocol-specified 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 lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.	Device: Lotrafilcon B contact lenses with color printing; Other Names: AIR OPTIX® COLORS
Active Comparator: FreshLook COLORBLENDS; Phemfilcon A contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.	Device: Phemfilcon A contact lenses with color printing; Other Names: FreshLook® COLORBLENDS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Comfort Likert Response at Day 30	Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Comfort Likert Response at Day 14	Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.	Day 14
Lens Comfort 1-10 Scale Response	Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.	Day 30

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Global Brand Lead, GCRA, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: September 14, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Contact lens; Vision care; Daily wear; Color contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: M-14-008