Comparison of Two Silicone Hydrogel Multifocal Contact Lenses

Study Overview
=================
Brief Summary
-----------------
This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.

Official Title
-----------------
Comparison of Two Silicone Hydrogel Multifocal Contact Lenses

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

Intervention / Treatment
-----------------
* Device: Dailies Total 1® Multifocal Contact Lenses
* Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential subjects must satisfy all 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 (inclusive). The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye. The subject's refractive cylinder must be ≤0.75 D in each eye. The subject's ADD power must be in the range of +0.75 D to +2.50 D. 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 (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration). The subject must either already be 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. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Currently pregnant or lactating. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 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 (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.). A history of amblyopia, strabismus or binocular vision abnormality. Any current ocular infection or inflammation. Any current ocular abnormality that may interfere with contact lens wear. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 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 7 days prior to study enrollment. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® multipurpose care solution, sodium fluorescein or single-use preservative free rewetting drop solution.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control<br>Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. | Device: Dailies Total 1® Multifocal Contact Lenses<br>* TEST<br>Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®<br>* CONTROL<br>|
| Experimental: Control/Test<br>Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. | Device: Dailies Total 1® Multifocal Contact Lenses<br>* TEST<br>Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®<br>* CONTROL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Lens Centration | Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported. | 6 to 8 days | 
| Percentage of Participants With Lens Movement | Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported. | 6 to 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Handling Scores | 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, aged 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. | 6 to 8 days |