Study of Soft Contact Lens Use With 7 Day Extended Wear

Study Overview
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Brief Summary
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To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.

Detailed Description
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To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.

Official Title
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An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen

Conditions
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Ametropia

Intervention / Treatment
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* Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens
* Device: Acuvue 2 Soft Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age as of the date of evaluation. Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes. Be correctable to visual acuities of at least 20/25 in each eye with spectacles. Be in good general health, based on his/her knowledge. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments. Possess wearable and visually functional eyeglasses. Exclusion Criteria: Previously unsuccessful with contact lens wear. Rigid gas permeable contact lens wear within the past 12 months. Previous refractive surgery; current or previous orthokeratology treatment. Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment. Aphakia, keratoconus or an irregular cornea. A known history of corneal hypoesthesia Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc. Slit lamp findings that would contraindicate contact lens wear, including but not limited to: History of corneal ulcer, corneal infiltrates or fungal infections. Pterygium, pinguecula or corneal scars within the visual axis Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia) Neovascularization or ghost vessels > 1mm in from the limbus Seborrheic eczema, seborrheic conjunctivitis History of papillary conjunctivitis greater than Grade 2 (Mild) Anterior uveitis or iritis (past or present) Known sensitivity to the care systems used in this study. Poor personal hygiene Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months. Any active participation in another clinical study within 30 days prior to this study. Subject is a member, relative or household member of the office staff, including the investigator(s). Subjects must read, indicate understanding of, and sign the Informed Consent Form.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Contact Lenses<br>VISA (comfilcon A) Silicone Hydrogel Soft contact lens | Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens<br>* Test device<br>* Other names: Biofinity (comfilcon A);|
| Active Comparator: Control Contact Lenses<br>Acuvue 2 Soft Contact Lens | Device: Acuvue 2 Soft Contact Lens<br>* Control device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of serious and significant AEs | Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Visual Acuity | Contact lens visual acuity was assessed using LogMAR | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, hyperopia, extended wear, ametropia