Clinical Evaluation of Multifocal Toric Contact Lenses

Study Overview
=================
Brief Summary
-----------------
This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.

Official Title
-----------------
Clinical Evaluation of Multifocal Toric Contact Lenses

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Device: etafilcon A Investigational Toric Multifocal Contact Lens
* Device: etafilcon A Investigational Toric Multifocal Contact Lens
* Device: etafilcon A Investigational Toric Multifocal Contact Lens
* Device: etafilcon A Investigational Toric Multifocal Contact Lens
* Device: etafilcon A Investigational Toric Multifocal Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol The subject must be between 40 and 70 years of age. The subject's distance refraction must be in the range of -1.50 D to -4.50 D. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye The subject must have best corrected visual acuity of 20/20-3 or better in each eye Subjects must own a wearable pair of spectacles if required for their distance vision The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration) The subject must already be wearing a presbyopic contact lens correction (eg, reading spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not respond positively to at least one symptom on the Presbyopic Systems Questionnaire. Exclusion Criteria: Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear Pregnancy or lactation Currently diagnosed with diabetes Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg, HIV). Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions Any previous, or planned, ocular or intraocular surgery (eg, radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc) A history of amblyopia, strabismus or binocular vision abnormality Any ocular infection or inflammation Any ocular abnormality that may interfere with contact lens wear Use of any ocular medication, with the exception of rewetting drops History of herpetic keratitis Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment Employee of clinical site (eg, Investigator, Coordinator, Technician).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 2<br>etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 3<br>etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 4<br>etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 5<br>etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 6<br>etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 7<br>etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 8<br>etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 9<br>etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|
| Experimental: Sequence 10<br>etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator) | Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 1<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 2<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Tes Lens 3<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Test Lens 4<br>Device: etafilcon A Investigational Toric Multifocal Contact Lens<br>* Control Lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Handling Comparison Between Test 1/Test 2 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Handling Comparison Between Test 3/Test 4 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 15 minutes |