Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Completed · Not applicable

Conditions studied: Refractive Ametropia

In brief

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Key facts

Study ID

NCT01484054

Run by

Johnson & Johnson Vision Care, Inc.

People needed

103

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…

• The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
• The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
• The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
• The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
• The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
• The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
• Any cylinder power must be:<=0.75D.
• The subject must have visual acuity best correctable to 20/25 or better for each eye.
• The subject must have normal eyes (no ocular medications or ocular infection of any type).
• The subject must read and sign the Statement of Informed Consent.
• The subject 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 (color blindness) - 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 is an employee or family member of the clinical study site.

Where it is running

• Study site — Bloomfield, Connecticut, United States
• Study site — Tallahassee, Florida, United States
• Study site — Overland Park, Kansas, United States
• Study site — Jamestown, New York, United States
• Study site — Kingston, Pennsylvania, United States
• Study site — Moon Township, Pennsylvania, United States

Full record on ClinicalTrials.gov

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