Comparison of Three Soft Bifocal Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: balafilcon A
* Device: senofilcon A production
* Device: senofilcon A test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must between 35 and 70 years of age. The subject must respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.). The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. Refractive cylinder must be less than or equal to -0.75 D in each eye. The subject must have an add power of +0.75D to +2.50D in each eye. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. The subject's must have at least 20/30-distance vision with the study contact lenses. The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses. The subject must be an adapted soft contact lens wearer in both eyes. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. Exclusion Criteria: Ocular or systemic allergies or disease that may interfere with contact lens wear. Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV). History of diabetes. History of binocular vision abnormality or strabismus.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilA test/senofilA prod/balafilconA<br>Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|
| Active Comparator: senofilcon A test/balafilcon A/senofilcon A prod<br>Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|
| Active Comparator: senofilcon A prod/senofilcon A test/balafilcon A<br>Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|
| Active Comparator: senofilcon A prod/ balifilcon A/ senofilcon A test<br>Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|
| Active Comparator: balafilcon A/senofilcon A test/senofilcon A prod<br>Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|
| Active Comparator: balafilcon A/senofilcon A prod/senofilcon A test<br>Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third. | Device: balafilcon A<br>* multifocal contact lens<br>Device: senofilcon A production<br>* multifocal contact lens<br>Device: senofilcon A test<br>* multifocal contact lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 5 minutes after insertion | 
| Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity | Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 5 minutes after insertion | 
| Type of Corneal Staining | Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm). | after 1 week of lens wear, for each lens type | 
| Overall Subjective Vision | Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor. | after 1 week of lens wear, for each lens type |