Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

Not Applicable

Completed

• Conditions: Presbyopia; Myopia
• Interventions: Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial

• Registration Number: NCT01254760
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-01
• Results First Submitted: 2012-01-17
• Results First Submitted QC: 2012-01-17
• Results First Posted: 2012-02-17
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Age 41 to 68 (inclusive).
• Spectacle add between +0.75 and +2.75D (inclusive).
• Habitual spectacle prescription ≤ 1.00DC (cyl).
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks of enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in a clinical trial.
• Prior refractive surgery.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational multifocal / Commercial multifocal	Nelfilcon A multifocal contact lens, investigational	Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Investigational multifocal / Commercial multifocal	Nelfilcon A multifocal contact lens, commercial	Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Commercial multifocal / Investigational multifocal	Nelfilcon A multifocal contact lens, investigational	Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Commercial multifocal / Investigational multifocal	Nelfilcon A multifocal contact lens, commercial	Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Primary Outcome Measures

Name	Time	Method
End of Day Comfort	5 days of wear, lenses replaced daily	End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
End of Day Dryness	5 days of wear, lenses replaced daily	End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Handling at Removal	5 days of wear, lenses replaced daily	Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Overall Vision	5 days of wear, lenses replaced daily	Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcome Measures

Name	Time	Method
Overall Fit	Day 5, lenses replaced daily	Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight