Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Completed · Not applicable

Conditions studied: Refractive Ametropia

In brief

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Key facts

Study ID

NCT01484028

Run by

Johnson & Johnson Vision Care, Inc.

People needed

275

Starts

2011-11-01

Expected to finish

2012-02-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 34. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Healthy, female adult, at least 18 years of age, and no more than 34 years of age
• The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
• Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
• Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
• Any cylinder power must be: <=0.75D
• Visual acuity must be best correctable to 20/25 or better for each eye
• Must have normal eyes (no ocular medications or ocular infection of any type)
• Must read and sign the Statement of Informed Consent
• Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

You may not qualify if…

• Ocular or systemic allergies or disease which might interfere with contact lens wear
• Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
• Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
• Any ocular infection
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
• Any color deficiencies (colorblindness) - to the best of the subject's knowledge
• Pregnancy or lactation
• Diabetes
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.
• Subject presents with one dark iris color and one light iris color.
• Subject has heterochromia iridis (a difference in color between parts of one iris).
• The subject must not be an employee or family member of the clinical study site.

Where it is running

• Advanced Optometry — Mission Viejo, California, United States
• James R Dugue, Optometrist — Mission Viejo, California, United States
• Advance Eye Care — Pismo Beach, California, United States
• Golden Vision — Sarasota, Florida, United States
• Eye Associates of Winter Park — Winter Park, Florida, United States
• Eye Care Associates — Bloomington, Illinois, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Vision Care — East Lansing, Michigan, United States
• Spectrum Eye Care — Jamestown, New York, United States
• Sacco Eye Group — Vestal, New York, United States
• The Eye Care Group — Grants Pass, Oregon, United States
• Dr. David W Ferris and Associates — Warwick, Rhode Island, United States
• Wishnow Sugar Group — Katy, Texas, United States
• Isthmus Eye Care — Middleton, Wisconsin, United States
• Snowy Range Cision Center — Laramie, Wyoming, United States

Full record on ClinicalTrials.gov

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