Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
Condition: Contact Lens Base Curve (BC) Fit and Comfort
Intervention: Contact Lenses with 8.5 BC; Contact Lenses with 9.0 BC
Intervention description: Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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).

        Exclusion Criteria:

          -  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)