Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

Completed · Phase 4

Conditions studied: Contact Lens Base Curve (BC) Fit and Comfort

In brief

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

Key facts

Study ID

NCT02537522

Run by

Johnson & Johnson Vision Care, Inc.

People needed

72

Starts

2015-07-01

Expected to finish

2015-07-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
• The subject must be willing and able to adhere to the instructions set out in the protocol.
• The subject must be an adapted soft contact lens wearer in both eyes.
• The subject must be willing to wear the study contact lenses up to 14 hours/day.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
• The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
• The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
• The subject must require a visual correction in both eyes (no monofit or monovision allowed).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

You may not qualify if…

• Current 1-DAY ACUVUE® TruEye® wearers
• Anisometropia of 1.00 D or greater
• Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
• Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, 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
• Pregnancy or lactation
• Diabetes
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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