A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens

The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 370
• 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:

• Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
• Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
• Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
• Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
• History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
• Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
• Monovision, monocular (only one eye with functional vision) or fit with only one lens.
• History of intolerance or hypersensitivity to any component of the test articles.
• Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
• Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
• Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
• Participation in any investigational clinical study within previous 30 days.
• 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 in daily wear modality for 4 weeks. 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 in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 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 Comfort	Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Rating of Overall Vision	Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.	Up to Day 28
Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)	Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.	Day 28

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

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

More Information

Terms related to this study

• Keywords: contact lenses; myopia; color contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C-12-005