Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA); Device: Balafilcon A contact lens (PureVision® 2); Device: Contact lens solution (Clear Care®)

• Registration Number: NCT01300767
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-04
• Results First Submitted: 2012-04-11
• Results First Submitted QC: 2012-04-11
• Results First Posted: 2012-05-09
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
• Willing and able to wear spherical contact lenses within the available range of powers.
• Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Astigmatism of 1.00D or more.
• Currently wearing contact lenses in a daily disposable modality.
• Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
• Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B	Contact lens solution (Clear Care®)	Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.
Balafilcon A	Contact lens solution (Clear Care®)	Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.
Lotrafilcon B	Lotrafilcon B contact lens (AIR OPTIX® AQUA)	Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.
Balafilcon A	Balafilcon A contact lens (PureVision® 2)	Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Daytime Vision	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Handling at Removal	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Comfort on Insertion	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Low Light Vision	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Delivers a Healthy, Natural Feeling	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Purchase Intent	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.
Comfort During the Day	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Comfort at End of Day	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Handling on Insertion	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Lens Awareness	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.
Overall Satisfaction	4 weeks	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.