Corneal and Conjunctival Sensitivity and Staining Study
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Intervention: Optifree RepleniSH Multipurpose Disinfecting Solution; ReNu Multiplus Multipurpose Solution
Intervention description: lens care system; lens care system
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 17 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to compare subjective symptoms and ocular health in a
      group of individuals who are currently wearing soft contact lenses on a daily wear basis,
      after a short period of no lens wear and during the time course when using differing care
      regimens.
    

Eligibility criteria:

        Inclusion Criteria:

        An eligible participant is one who:

          -  Is between 17-45 years old and has full legal capacity to volunteer.

          -  Has read and signed an information consent letter, after having the opportunity to ask
             questions and receive acceptable answers.

          -  Is willing and able to follow instructions and maintain the appointment schedule.

          -  Does not experience any dryness related symptoms during lens wear (i.e. at least 12
             hours of comfortable wearing time)

          -  Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their
             habitual vision correction.

          -  Has normal binocular vision (no strabismus, no amblyopia).

          -  Has clear corneas and no active ocular disease.

          -  Has had an ocular examination in the last two years. Has a distance contact lens
             prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.

          -  Has astigmatism less than or equal to -1.00DC.

          -  Agrees to wear the study lenses on a daily wear basis.

          -  Has a pair of glasses with updated prescription and agrees to wear them during the
             period no lens wear (7-10 days) as required by the study.

        Exclusion Criteria:

        A person is ineligible if he/she:

          -  Has undergone corneal refractive surgery.

          -  Is aphakic.

          -  Has any active ocular disease.

          -  Has any systemic disease affecting ocular health.

          -  Is using any systemic or topical medications that may affect ocular health.

          -  Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.

          -  Is pregnant or lactating.

          -  Is participating in any other clinical or research study.

          -  Has a known clinically significant sensitivity to the contact lens care solutions used
             in the study.

          -  Has ocular or systemic allergies that could adversely affect contact lens wear.

          -  Currently wears lenses on a continuous or extended wear basis.

          -  Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that
             would affect the wearing of contact lenses.

          -  Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear
             inadvisable.

          -  Is a rigid lens wearer.

          -  Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in
             either eye, sum of corneal staining type (severity) of greater than or equal to 4
             across the entire cornea in either eye, or any corneal staining covering greater than
             or equal to 20% in any corneal region in either eye.