Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Completed · Not applicable

Conditions studied: Astigmatism

In brief

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Key facts

Study ID

NCT01055132

Run by

Johnson & Johnson Vision Care, Inc.

People needed

70

Starts

2010-01-01

Expected to finish

2010-02-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject must be between 18 and 40 years old.
• The subject must have normal eyes.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
• The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
• The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
• The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
• The subject must be an adapted wearer of soft toric contact lenses in both eyes.
• The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
• Subjects must already possess a wearable pair of spectacles.

You may not qualify if…

• Ocular or systemic allergies or disease that may interfere with contact lens wear.
• Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation
• Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Diabetes
• Strabismus

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — New York, New York, United States
• Study site — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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