Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product

Study Overview
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Brief Summary
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This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.

Official Title
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Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: senofilcon A C3
* Device: Dailies Total 1 Multifocal Contact Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all 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 years of age and not greater than 70 years of age at the time of consent. 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 a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration). 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. 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 +3.75 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 distance best corrected 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. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. Have 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). Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). Have a history of amblyopia, strabismus or binocular vision abnormality. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples. Use of any ocular medication, with the exception of rewetting drops. Have a history of herpetic keratitis. Have a history of irregular cornea. Have a history of pathological dry eye. Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein. Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. Have any current ocular infection or inflammation. Have any current ocular abnormality that may interfere with contact lens wear.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEST Lens<br>Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study. | Device: senofilcon A C3<br>* TEST Lens<br>|
| Experimental: CONTROL Lens<br>Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study. | Device: Dailies Total 1 Multifocal Contact Lenses<br>* CONTROL Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 1-Week Follow-up | 
| CLUE Vision Score | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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 average CLUE vision score for each lens type was reported. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance logMAR Visual Acuity | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 1-Week Follow-up |