Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

Study Overview
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Brief Summary
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This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Detailed Description
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This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Official Title
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Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses

Conditions
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Presbyopia, Astigmatism

Intervention / Treatment
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* Device: comfilcon A multifocal toric lens
* Device: omafilcon A Multifocal Toric Lens


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 aged 40-75 years, inclusive and has full legal capacity to volunteer. Has read and understood the participant information sheet. 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 -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye. Can be satisfactorily fitted with the study lenses. Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected. They have successfully worn soft contact lenses in the last six months Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination. Has an up-to-date pair of spectacles. Exclusion Criteria: 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, in the opinion of the investigator, affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Has a history of anaphylaxis or severe allergic reaction. Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator. They are pregnant or breast-feeding. 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Multifocal Toric Lens<br>comfilcon A multifocal toric lens | Device: comfilcon A multifocal toric lens<br>* contact lens<br>* Other names: Biofinity multifocal toric lens;Device: omafilcon A Multifocal Toric Lens<br>* contact lens<br>* Other names: Control multifocal toric lens;|
| Active Comparator: omafilcon A Multifocal Toric Lens<br>Control multifocal toric lens | Device: comfilcon A multifocal toric lens<br>* contact lens<br>* Other names: Biofinity multifocal toric lens;Device: omafilcon A Multifocal Toric Lens<br>* contact lens<br>* Other names: Control multifocal toric lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual Acuity (measured in LogMAR) | Up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Up to 2 hours | 
| Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity | Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Up to 2 hours | 
| Assessment of Visual Performance: Near Task for Vision Quality and Clarity | Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Up to 2 hours |