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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Contact Lenses | Experimental | VISA (comfilcon A) Silicone Hydrogel Soft contact lens |
|
| Control Contact Lenses | Active Comparator | Acuvue 2 Soft Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISA (comfilcon A) Silicone Hydrogel Soft contact lens | Device | Test device |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Visual Acuity | Contact lens visual acuity was assessed using LogMAR | 1 Year |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| William Gleason, OD | FRS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Mesa Vision Care Center | La Mesa | California | 91941 | United States | ||
| (Private Practice) |
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| Acuvue 2 Soft Contact Lens | Device | Control device |
|
| San Diego |
| California |
| 92123 |
| United States |
| Drs. Cook, Reeder and Associates | San Diego | California | 92129 | United States |
| (Private Practice) | Santa Monica | California | 90403 | United States |
| Eye Care Associates, P.C. | Fort Collins | Colorado | 80521 | United States |
| Eola Eyes | Orlando | Florida | 32801 | United States |
| (Private Practice) | Honolulu | Hawaii | 96814 | United States |
| Kato & Shoji Optometrists | Honolulu | Hawaii | 96815 | United States |
| Eye Care Associates of Hawaii | Waipahu | Hawaii | 96797 | United States |
| Davis Eyecare Associates | Oak Lawn | Illinois | 60453 | United States |
| (Private Practice) | Andover | Massachusetts | 01810 | United States |
| Vision Care Associates | East Lansing | Michigan | 48823 | United States |
| The Koetting Associates Inc. | St Louis | Missouri | 63144 | United States |
| Concord Ophthalmological Associates | Concord | New Hampshire | 03301 | United States |
| Place Optical Company Inc | Le Roy | New York | 14482 | United States |
| Quinn Quinn & Associates | Athens | Ohio | 45701 | United States |
| Western Reserve Vision Care | Beachwood | Ohio | 44122 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Professional Eye Care Associates | Columbus | Ohio | 43215 | United States |
| Primary Eyecare Group, P.C. | Brentwood | Tennessee | 37027 | United States |
| (Private Practice) | Salt Lake City | Utah | 84106 | United States |
| Twin Lakes Vision | Federal Way | Washington | 98023 | United States |
| Snowy Range Vision Center | Laramie | Wyoming | 82070 | United States |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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