CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

Study Overview
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Brief Summary
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A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.

Conditions
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Presbyopia Correction

Intervention / Treatment
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* Device: Test (multi-focal)
* Device: Control (Sphere)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45 years or more Spectacle or soft contact lens wearer Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D Best spectacle corrected visual acuity of 6/9 or better in each eye Willingness to adhere to the instructions set forth in the clinical protocol Signature of the subject Informed Consent form after review of Information to Participant document. Exclusion Criteria: Systemic or ocular allergies which might interfere with contact lens wear Systemic disease which might interfere with contact lens wear Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion) Use of medication which might interfere with contact lens wear Active ocular infection Use of ocular medication Significant ocular anomaly Presence of two or more corneal scars in either eye Monovision contact lens wearers Pregnancy or lactation Any medical condition that might be prejudicial to the study Participants non-able to give consent or from a vulnerable group Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.) Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)

Ages Eligible for Study
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Minimum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control (sphere) /Test (multi-focal)<br>Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week. | Device: Test (multi-focal)<br>* contact lens was to be worn a daily wear.<br>* Other names: filcon II 3;Device: Control (Sphere)<br>* contact lens was to be worn a daily wear with spectacles<br>* Other names: filcon II 3;|
| Other: Test (sphere) /Control (multi-focal)<br>Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week. | Device: Test (multi-focal)<br>* contact lens was to be worn a daily wear.<br>* Other names: filcon II 3;Device: Control (Sphere)<br>* contact lens was to be worn a daily wear with spectacles<br>* Other names: filcon II 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance LogMAR Visual Acuity | Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%) | 7 days post wear | 
| Near LogMAR Visual Acuity | Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%) | 7 days post wear |