A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Study Overview
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Brief Summary
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The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Detailed Description
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This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Official Title
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A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Device: comfilcon A Extended Range test lens
* Device: comfilcon A control lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Has had a self-reported oculo-visual examination in the last two years Is 50 years of age or greater and has full legal capacity to volunteer Is able to read and understand the informed consent Is willing and able to follow instructions and maintain the appointment schedule Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive) Near Add Power requirement of +2.25D or greater Has spectacle cylinder 0.75 D in both eyes Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D) Has monocular best-corrected distance visual acuity of 20/30 or better in each eye Has clear corneas and no active ocular disease Has not worn gas permeable contact lenses for 1 month prior to the study 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 abnormality that would affect the wearing of contact lenses Is aphakic (i.e. missing their natural lens inside their eye) Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D 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: 50 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 Extended Range test lens<br>Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. | Device: comfilcon A Extended Range test lens<br>* contact lens<br>Device: comfilcon A control lens<br>* contact lens<br>|
| Active Comparator: comfilcon A control lens<br>Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. | Device: comfilcon A Extended Range test lens<br>* contact lens<br>Device: comfilcon A control lens<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. | 4 days | 
| Visual Performance | Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings for Comfort | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Baseline | 
| Subjective Ratings for Comfort | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | 4 days | 
| Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | Baseline | 
| Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | 4 days | 
| Lens Handling | Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). | 4 Days | 
| Average Daily Wearing Time | Average daily wearing time for test and control lens is assessed in hours. | 4 days | 
| Lens Fit | Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit. | 4 days | 
| Bulbar Hyperemia | Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | 4 days | 
| Limbal Hyperemia | Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | 4 days | 
| Subjective Satisfaction | Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied) | 4 days | 
| Subjective Preference for Near Vision | Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction. | 4 days | 
| Subjective Preference for Distance Vision | Subjective preference for distance vision for test and control contact lenses. | 4 days | 
| Subjective Preference for Intermediate Vision | Subjective preference for intermediate vision for test and control contact lenses. | 4 days | 
| Subjective Preference for Overall Vision | Subjective preference for overall vision for test and control contact lenses. | 4 days | 
| Subjective Preference for Comfort | Subjective preference for comfort for test and control contact lenses. | 4 days | 
| Subjective Overall Lens Preference | Subjective overall lens preference for test and control contact lenses. | 4 days |