Handling Comparison Between Two Contact Lens Types

Study Overview
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Brief Summary
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Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Conditions
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Presbyopia

Intervention / Treatment
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* Device: etafilcon A (multi-focal)
* Device: etafilcon A (sphere)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye. The subject's refractive cylinder must be less than or equal to -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 best corrected visual acuity of 20/20 -3 or better in each eye. Subject must own a wearable pair of spectacles. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration) The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the Presbyopic Symptoms Questionnaire. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Any ocular abnormality that may interfere with contact lens wear. Use of any ocular medication, with the exception of rewetting drops. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. Any ocular infection or inflammation. History of herpetic keratitis. Any corneal distortion or irregular cornea. History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV). Current history of diabetes. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etafilcon A(sphere)/etafilcon A(multi-focal)<br>Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second. | Device: etafilcon A (multi-focal)<br>* Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.<br>* Other names: Investigational Multifocal Contact;Device: etafilcon A (sphere)<br>* Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.<br>* Other names: 1-DAY ACUVUE® MOIST®;|
| Active Comparator: etafilcon A(multi-focal)/etafilcon A(sphere)<br>Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second. | Device: etafilcon A (multi-focal)<br>* Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.<br>* Other names: Investigational Multifocal Contact;Device: etafilcon A (sphere)<br>* Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.<br>* Other names: 1-DAY ACUVUE® MOIST®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | 15 minutes post Contact Lens Insertion |