Multifocal Contact Lenses Fitting Methods Comparison

Study Overview
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Brief Summary
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This study compares two fitting approaches to multifocal contact lenses.

Detailed Description
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This study compares two common fitting approaches to fit Silicone Hydrogel Multifocal contact lenses to assess which one achieves the best results to support proposing that fitting approach for the selection of the first contact lenses to try.

Official Title
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Biofinity Multifocal Contact Lenses Fitting Methods Comparison

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Control Lenses
* Device: Test Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 40 years old; Have read and understood the Participant Information Sheet; Have read, signed and dated the Informed Consent; Best corrected visual acuity of at least 20/25 in each eye; Have normal eyes with the exception of the need for visual correction; Current multifocal contact lens wearer; Spectacle refraction: Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule. Exclusion Criteria: Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; Monocular participants (only one eye with functional vision) or participants fit with only one lens; Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit; History of herpetic keratitis, ocular surgery or irregular cornea; Known pregnancy or lactation during the study period; Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silicone Hydrogel Multifocal Control Lenses<br>Participant will wear Control Lenses for one week, then crossover to Experimental Lenses for one week. | Device: Control Lenses<br>* D design fitted to both dominant and non-dominant eyes<br>Device: Test Lenses<br>* D design fitted to dominant eye and N design fitted to non-dominant eye<br>|
| Experimental: Silicone Hydrogel Multifocal Test Lenses<br>Participant will wear Test Lenses for one week, then crossover to Control Lenses for one week. | Device: Control Lenses<br>* D design fitted to both dominant and non-dominant eyes<br>Device: Test Lenses<br>* D design fitted to dominant eye and N design fitted to non-dominant eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall binocular vision satisfaction | Overall binocular vision satisfaction will be measured on a 100-point Visual Analog Scale where 0 represents extremely unsatisfied and 100 is extremely satisfied. | one week of wear | 
| Overall preference | Overall preference is measured on a forced choice scale, where the responses to the question Please indicate below which lenses you worn in the study you prefer for overall vision by selecting first lens or the second lens from the drop-down menu. are as follows: Prefer contact lens 1 strongly Prefer contact lens 1 slightly No preference Prefer contact lens 2 slightly Prefer contact lens 2 strongly | one week of wear each | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean binocular visual performance visual acuity | Mean binocular visual performance measured by timed logMAR charts (this is the mean of distance and near visual acuities) | one week of wear | 
| Number of contact lenses needed per participant to determine the contact lens pair to be dispensed | Number of contact lenses needed per participant to determine the contact lens pair to be dispensed | one week of wear each |