Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Nelfilcon A contact lens; Device: Narafilcon B contact lens

• Registration Number: NCT01233076
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-03
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2011-08-05
• Results First Posted: 2011-09-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
• Able to wear study lenses in the available powers from -1.00D to -6.00D.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury within twelve weeks of enrollment.
• History of corneal or refractive surgery.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
• Monovision correction during the study.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nelfilcon A / Narafilcon B	Nelfilcon A contact lens	Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Narafilcon B / Nelfilcon A	Nelfilcon A contact lens	Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Narafilcon B / Nelfilcon A	Narafilcon B contact lens	Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Nelfilcon A / Narafilcon B	Narafilcon B contact lens	Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.

Primary Outcome Measures

Name	Time	Method
Overall Vision Quality	1 week of wear	Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.