Study of Soft Contact Lens Use With 7 Day Extended Wear
NCT ID: NCT00597467
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
460 participants
INTERVENTIONAL
2006-03-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Contact Lenses
VISA (comfilcon A) Silicone Hydrogel Soft contact lens
VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
Control Contact Lenses
Acuvue 2 Soft Contact Lens
Acuvue 2 Soft Contact Lens
Control device
Interventions
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VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
Acuvue 2 Soft Contact Lens
Control device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
4. Be in good general health, based on his/her knowledge.
5. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
6. Possess wearable and visually functional eyeglasses.
Exclusion Criteria
2. Rigid gas permeable contact lens wear within the past 12 months.
3. Previous refractive surgery; current or previous orthokeratology treatment.
4. 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.
5. Aphakia, keratoconus or an irregular cornea.
6. A known history of corneal hypoesthesia
7. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
8. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
9. 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)
10. Known sensitivity to the care systems used in this study.
11. Poor personal hygiene
12. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
13. Any active participation in another clinical study within 30 days prior to this study.
14. 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.
18 Years
ALL
Yes
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Gleason, OD
Role: STUDY_DIRECTOR
FRS
Locations
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La Mesa Vision Care Center
La Mesa, California, United States
(Private Practice)
San Diego, California, United States
Drs. Cook, Reeder and Associates
San Diego, California, United States
(Private Practice)
Santa Monica, California, United States
Eye Care Associates, P.C.
Fort Collins, Colorado, United States
Eola Eyes
Orlando, Florida, United States
(Private Practice)
Honolulu, Hawaii, United States
Kato & Shoji Optometrists
Honolulu, Hawaii, United States
Eye Care Associates of Hawaii
Waipahu, Hawaii, United States
Davis Eyecare Associates
Oak Lawn, Illinois, United States
(Private Practice)
Andover, Massachusetts, United States
Vision Care Associates
East Lansing, Michigan, United States
The Koetting Associates Inc.
St Louis, Missouri, United States
Concord Ophthalmological Associates
Concord, New Hampshire, United States
Place Optical Company Inc
Le Roy, New York, United States
Quinn Quinn & Associates
Athens, Ohio, United States
Western Reserve Vision Care
Beachwood, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Professional Eye Care Associates
Columbus, Ohio, United States
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States
(Private Practice)
Salt Lake City, Utah, United States
Twin Lakes Vision
Federal Way, Washington, United States
Snowy Range Vision Center
Laramie, Wyoming, United States
Countries
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Other Identifiers
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CVI060105
Identifier Type: -
Identifier Source: org_study_id
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