AIR OPTIX® COLORS Registration Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Lotrafilcon B contact lens with color
* Device: Lotrafilcon B contact lens


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Contact lenses