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

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

Conditions
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Presbyopia, Myopia

Intervention / Treatment
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* Device: Nelfilcon A multifocal contact lens, investigational
* Device: Nelfilcon A multifocal contact lens, commercial


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |