Study of Soft Contact Lens Use With 7 Day Extended Wear

Completed · Not applicable

Conditions studied: Ametropia

In brief

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.

Key facts

Study ID

NCT00597467

Run by

CooperVision, Inc.

People needed

460

Starts

2006-03-01

Expected to finish

2007-11-01

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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