Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Study Overview
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Brief Summary
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The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Detailed Description
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The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.

Official Title
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Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Conditions
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Astigmatism, Presbyopia

Intervention / Treatment
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* Device: comfilcon A
* Device: Samfilcon A


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 soft contact lens for the past 3 months minimum; Has refractive astigmatism of at least -0.75DC; Is presbyopic and requires a reading addition of at least +0.75D; 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; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50). 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; 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 and/or the care product Opti-Free PureMoist being used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery. * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Ages Eligible for Study
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Minimum Age: 17 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: comfilcon A then samfilcon A<br>Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. | Device: comfilcon A<br>* Subjects will be randomized to wear comfilcon A for one month.<br>* Other names: Biofinity Toric Multifocal;Device: Samfilcon A<br>* Subjects will be randomized to wear samfilcon A for one month.<br>* Other names: Ultra Multifocal for Astigmatism;|
| Active Comparator: samfilcon A then comfilcon A<br>Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study. | Device: comfilcon A<br>* Subjects will be randomized to wear comfilcon A for one month.<br>* Other names: Biofinity Toric Multifocal;Device: Samfilcon A<br>* Subjects will be randomized to wear samfilcon A for one month.<br>* Other names: Ultra Multifocal for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Lens Handling at Insertion | Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy). | Day 28 |