Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population

Study Overview
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Brief Summary
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The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.

Official Title
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Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Toric Multifocal etafilcon A with PVP


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 at least 40 and not more than 70 years of age at the time of screening. The subject's distance spherical component of their refraction must be in the range of +1.25 D to +3.75 D in each eye. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye. The subject's ADD power must be in the range of +0.75 D to +1.50 D in each eye. Subject's refractive cylinder axis must be within 90°±30° or 180°±30° in each eye. 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 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, 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 30 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 Eye-Cept® rewetting drop solution.

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: Test Lens<br>Subjects between the ages 40 to 70 years of age and who are adapted contact lens wearers with astigmatism in both eyes will be assigned to the same Test Lens according to the lens wear schedule. | Device: Toric Multifocal etafilcon A with PVP<br>* Investigational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (logMAR) | High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | 2-Week Follow-up | 
| Near Visual Acuity (logMAR) | High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | 2-Week Follow-up |