Evaluation of Two Marketed Multifocal Contact Lenses

Study Overview
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Brief Summary
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This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Official Title
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Evaluation of Two Marketed Multifocal Contact Lenses

Conditions
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Visual Performance

Intervention / Treatment
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* Device: Multifocal Contact Lens 1
* Device: Multifocal Contact Lens 2
* Device: Spherical Contact Lens 2


Participation Criteria
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Eligibility Criteria
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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 at least 40 years of age and not greater than 70 years of age. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D. 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 in each eye. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. The subject must own a pair of wearable 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 or more duration). The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or 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: 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 (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. 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 (e.g., 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 (e.g., Investigator, Coordinator, Technician)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative<br>Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period. | Device: Multifocal Contact Lens 1<br>* Dailies Total 1 Multifocal Contact Lens<br>* Other names: Test 1 Multifocal , delefilcon A;Device: Multifocal Contact Lens 2<br>* Biotrue ONEday for Presbyopia Contact Lenses<br>* Other names: Test 2 Multifocal, nesofilcon A;Device: Spherical Contact Lens 2<br>* BioTrue ONEDay Spherical<br>* Other names: Test 2 Alternative, nesofilcon A;|
| Active Comparator: Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal<br>Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period. | Device: Multifocal Contact Lens 1<br>* Dailies Total 1 Multifocal Contact Lens<br>* Other names: Test 1 Multifocal , delefilcon A;Device: Multifocal Contact Lens 2<br>* Biotrue ONEday for Presbyopia Contact Lenses<br>* Other names: Test 2 Multifocal, nesofilcon A;Device: Spherical Contact Lens 2<br>* BioTrue ONEDay Spherical<br>* Other names: Test 2 Alternative, nesofilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Binocular Visual Acuity | Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. | 1-Week Follow-up | 
| Near Binocular Visual Acuity | Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Vision | Overall quality of 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. | 1-Week Follow-up |