A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon B contact lens with color; Device: Lotrafilcon B contact lens

• Registration Number: NCT01635920
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.

Detailed Description

Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-02
• Results First Submitted: 2014-02-18
• Results First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Results First Posted: 2014-03-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
• Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
• Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
• Other protocol-specified inclusion criteria may apply.

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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 (OTC) or prescribed topical ocular medications within 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 that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
• Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
• Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
• Participation in any investigational clinical study within previous 30 days.
• Other protocol-specified 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 bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
AIR OPTIX® AQUA	Lotrafilcon B contact lens	Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Same Fit in Both Eyes	Up to Day 28	Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.

Secondary Outcome Measures

Name	Time	Method
Subjective Rating of Overall Comfort	Up to Day 28	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.