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Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
CompletedNA
Sponsor: Johnson & Johnson Vision Care, Inc.
Conditions: Refractive Error
Interventions: galyfilcon A, comfilcon A
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
Eligibility overview
Sex: ALL
Age: 18 Years to 39 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes. * The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder. * The subject, based on his/her knowledge, must be in good general health. * The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations. * Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear. * Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. * Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period. * The subject must read, indicate understanding of and sign the Informed Consent Form. Exclusion Criteria: * The subject is a rigid gas permeable (RGP) or daily disposable lens wearer. * The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures. * The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.) * Slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium or corneal scars within the visual axis * neovascularization equal to or greater than 1mm in from the limbus * history of giant papillary conjunctivitis (GPC) worse than grade 2 * anterior uveitis or iritis (past or present) * seborrhoeic eczema * seborrhoeic conjunctivitis * A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. * A known history of corneal hypoesthesia (reduced corneal sensitivity). * Contact lens snellen visual acuities (VA) worse than 20/30. * Aphakia, keratoconus or a highly irregular cornea. * Current pregnancy or lactation (to the best of the subject's knowledge) * Any active participation in another clinical study at any time during this study.