Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

Study Overview
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Brief Summary
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This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Detailed Description
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This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Official Title
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Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Comfilcon A lens (test)
* Device: Omafilcon B lens (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has had a self-reported oculo-visual examination in the last two years. Is between ages 40-75 years, inclusive and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is able to participate in Parts A and B related to this work. Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive). Has an Add component to their spectacle refraction (between +0.75 and +2.50DS). Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected. Currently wears soft contact lenses. Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comfilcon A lens (test)<br>Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. | Device: Comfilcon A lens (test)<br>* contact lens<br>* Other names: Biofinity multifocal toric Lens (test);|
| Active Comparator: Omafilcon B Lens (control)<br>Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. | Device: Omafilcon B lens (control)<br>* contact lens<br>* Other names: Proclear multifocal toric lens (control);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity is assessed for test and control lens on a logMAR chart | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | up to 3 hours | 
| Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity | Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | up to 3 hours | 
| Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | up to 3 hours |