Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact lenses.

Official Title
-----------------
Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be at least 40 and not more than 70 years of age at the time of screening. Own a wearable pair of spectacles if required for their distance vision. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses for at least 8 hours per day at least two days per week for the past 4 weeks). Be already wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire. The subject's distance spherical component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +3.75 D. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye, with the cylinder axes in the range of 90°±30°. 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 distance visual acuity of 20/20-3 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Be currently pregnant or lactating. By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. Use systemic medications that may interfere with contact lens wear or cause blurred vision. Currently use ocular medication (with the exception of rewetting drops). Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.). Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report. Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Have a history of amblyopia or strabismus, by self-report. Have a history of herpetic keratitis, by self-report. Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JJVC Investigational Multifocal Toric Contact Lens<br>Eligible subjects that are adapted contact lens wearers with presbyopia, ametropia (hyperopia or myopia) and astigmatism will be dispensed the study lens in a bilateral fashion. | Device: JJVC Investigational Multifocal Toric Contact Lens<br>* TEST<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision | Overall vision 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. | 2-Week Follow-up | 
| LogMAR Visual Acuity | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m),intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR. | 2-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline CLUE Vision Score | Overall vision 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. The change from baseline was calculated as the 2 week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. | Up to 2-Week Follow-up | 
| Change From Baseline CLUE Comfort Score | Overall comfort 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. The change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. | Up to 2-Week Follow-up | 
| Change From Baseline CLUE Handling Score | 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. The change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. | Up to 2-Week Follow-up |