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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Myopia
• Intervention / Treatment: Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Investigational multifocal / Commercial multifocal; 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.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Names: Focus® DAILIES® Progressive
Other: Commercial multifocal / Investigational multifocal; 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.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Names: Focus® DAILIES® Progressive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Day Comfort	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.	5 days of wear, lenses replaced daily
End of Day Dryness	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.	5 days of wear, lenses replaced daily
Handling at Removal	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.	5 days of wear, lenses replaced daily
Overall Vision	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.	5 days of wear, lenses replaced daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Fit	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	Day 5, lenses replaced daily

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: P-416-C-001 Sub 04