Evaluating Two Multifocal Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The objective of the study is to adapt existing multifocal soft lens wearers to a CONTROL lens for at least 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Detailed Description
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This is a prospective, bilateral eye, open label, daily wear switch study involving daily disposable multifocal lenses. There will be no randomisation.

Official Title
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Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Control Contact Lens
* Device: Test 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; Has refractive astigmatism no higher than -0.75DC in each eye; Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D in each eye; 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 (powers +4.00 to -6.00DS) Exclusion Criteria: Is participating in any concurrent clinical or research study; 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Contact Lens<br>Subjects will wear Control contact lens for the first period of 2 weeks (14-21 days) and Test contact lens for the second period of 2 weeks (14-21 days). | Device: Control Contact Lens<br>* Control Contact Lens - first period of 2 weeks (14-21 days)<br>* Other names: Multifocal Daily Disposable Contact Lens;|
| Experimental: Test Contact Lens<br>Subjects will wear Test contact lens for the second period of 2 weeks (14-21 days). | Device: Test Contact Lens<br>* Test Contact Lens - second period of 2 weeks (14-21 days)<br>* Other names: Multifocal Daily Disposable Contact Lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Just After Lens Insertion | Comfort Just After Lens Insertion will be measured on a scale of 0-10 ratings, where 0=Painful, 10=Can't feel the lenses | 2 weeks |