Comparing the Performance of 1 Day Multifocal Contact Lenses

Study Overview
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Brief Summary
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The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Detailed Description
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The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Official Title
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Comparing the Performance of 1 Day Multifocal Contact Lenses

Conditions
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Presbyopia

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


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; 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 (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH). Exclusion Criteria: Is participating in any concurrent clinical or research study; Habitually wears one of the study contact lenses; 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: Lens A (Test)<br>Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study. | Device: Lens A<br>* Subjects will be randomized to wear Lens A (test) for 2 weeks.<br>* Other names: FDA Approved, non-marketed, daily disposable multifocal lens;Device: Lens B<br>* Subjects will be randomized to wear Lens B (control) for 2 weeks.<br>* Other names: FDA Approved, daily disposable multifocal lens;Device: Habitual Lenses<br>* All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.<br>|
| Active Comparator: Lens B (Control)<br>Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study. | Device: Lens A<br>* Subjects will be randomized to wear Lens A (test) for 2 weeks.<br>* Other names: FDA Approved, non-marketed, daily disposable multifocal lens;Device: Lens B<br>* Subjects will be randomized to wear Lens B (control) for 2 weeks.<br>* Other names: FDA Approved, daily disposable multifocal lens;Device: Habitual Lenses<br>* All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.<br>|
| Active Comparator: Habitual Lenses<br>All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B. | Device: Habitual Lenses<br>* All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective At-home Ratings for Ease of Lens Handling for Insertion | Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy) | Day 13 |