AIR OPTIX® COLORS Registration Trial

The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

Study Overview

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

Detailed Description

This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
• Normal eyes and not using any ocular medications.
• Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
• Manifest cylinder less than or equal to 0.75 diopter.
• Best spectacle corrected visual acuity greater than or equal to 20/25.
• Have current prescription glasses.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality.
• Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
• Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of refractive surgery or irregular cornea.
• History of pathologically dry eye.
• Corneal vascularization greater than 1 millimeter of penetration.
• History of herpetic keratitis.
• Eye injury within 12 weeks immediately prior to enrollment in this trial.
• Currently enrolled in any clinical trial or participation in any clinical trial within the 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIR OPTIX® COLORS; Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months	Device: Lotrafilcon B contact lens with color; Silicone hydrogel contact lens with color; Other Names: AIR OPTIX® COLORS
Active Comparator: AIR OPTIX® AQUA; Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months	Device: Lotrafilcon B contact lens; Silicone hydrogel contact lens; Other Names: AIR OPTIX® AQUA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)	Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.	Up to Month 3

Secondary 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 Month 3
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 Month 3
Subjective Rating of Overall Handling	Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.	Up to Month 3
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)	Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.	Up to Month 3
Lens Centration (Centered, Slight Decentration)	Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.	Up to Month 3
Dry Areas/Non-Wetting (None, Very Slight)	Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.	Up to Month 3
Front Surface Deposits (None, Very Slight)	Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.	Up to Month 3
Back Surface Deposits (None, Very Slight)	Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.	Up to Month 3

Collaborators and Investigators

• Sponsor: CIBA VISION
• Investigators: Study Director: Sharon Holden Thomas, OD, Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 26, 2011

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Myopia; Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: P-383-C-003 (C-11-032)