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

N/ACompletedNCT01254760

CIBA VISION79 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Presbyopia Myopia

Interventions

Nelfilcon A multifocal contact lens, investigationalDEVICE

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Nelfilcon A multifocal contact lens, commercialDEVICE

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Eligibility

Sex: ALLMin age: 41 YearsMax age: 68 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 5 days of wear, lenses replaced daily

Secondary Outcomes

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

Time frame: Day 5, lenses replaced daily

Data from ClinicalTrials.gov

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