Clinical Evaluation of Investigational Multifocal Contact Lenses

Study Overview
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Brief Summary
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3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.

Official Title
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Clinical Evaluation of Investigational Multifocal Contact Lenses

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: etafilcon A


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. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age. 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 if not, respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire.(Appendix B). The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study). The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye. The subject's refractive cylinder axis must be 90°±30° or 180°±30° 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 distance visual acuity of 20/20-3 or better in each eye. The subject must have a wearable pair of spectacles if required for their distance vision. Exclusion Criteria: 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participating Subjects<br>Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits. | Device: etafilcon A<br>* Investigational Contact Lens<br>|

What is the study measuring?
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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. | 12-16 Day Follow-up |