Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Study Overview
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Brief Summary
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The objective of the study is to compare the lens performance of two daily disposable multifocal contact lenses.

Detailed Description
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This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 3-4 weeks: the lens prescription of each lens type will be optimized after 3-8 days wearing experience, prior to starting a 2-week (14-21 day) wear period.

Official Title
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Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)
* Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 42 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears multifocal soft contact lenses, for the past 3 months minimum^; Maximum of 7 participants per site should be habitual wearers of daily disposable lenses Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL Maximum of 3 habitual wearers per site of MyDay Multifocal Maximum of 7 participants per site should be habitual wearers of frequent replacement lenses Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA Has refractive astigmatism no higher than -0.75DC; Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D; Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design). Exclusion Criteria: Is participating in any concurrent clinical or research trial; Has any known active* ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Ages Eligible for Study
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Minimum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Control Contact Lens, Then Test Contact Lens<br>Participants will wear control contact lenses for two weeks and then crossover to test contact lenses for two weeks. | Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)<br>* two weeks of wear<br>Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)<br>* two weeks of wear<br>|
| Experimental: Test Contact Lens, Then Control Contact Lens<br>Participants will wear test contact lenses for two weeks and then crossover to control contact lenses for two weeks. | Device: Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)<br>* two weeks of wear<br>Device: Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)<br>* two weeks of wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling for Removal | Lens Handling for Removal, using a 0-100 scale (0=Very difficult, 100=Very easy) | 2 weeks of wear |