Clinical Evaluation of Two Multifocal Contact Lenses

Study Overview
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Brief Summary
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The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

Detailed Description
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This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

Official Title
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Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Lens A
* Device: Lens B


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, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum. 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 (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
Interventional Model Description: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A<br>All participants wore lens A for 15 minutes (Period 1) | Device: Lens A<br>* monthly replacement multifocal silicone hydrogel contact lens 15 minutes of daily wear<br>|
| Experimental: Lens B<br>All participants wore lens B for 15 minutes (Period 2) | Device: Lens B<br>* daily disposable multifocal silicone hydrogel contact lens 15 minutes of daily wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort Ratings on Insertion | Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel. | At insertion |