Daily Wear Corneal Infiltrative Event Study
Condition: Myopia; Hyperopia; Corneal Infiltrative Events
MeSH terms: Hyperopia
Intervention: lotrafilcon A contact lenses; Renu Multiplus; Clear Care
Intervention description: FDA approved soft contact lenses
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 218.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and
      marketed lotrafilcon A (Ciba Vision, Air Optix Night & Day Aqua) soft contact lenses for
      daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic
      (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use
      will be followed for 1 year. The primary outcome is the risk of development of a corneal
      inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main
      exposure of interest is microbial contamination of study lenses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient must be at least 15 years old.

          2. The patient must be free of any anterior segment disorders.

          3. The patient must have a spectacle corrected spherical refractive error between +5.50 D
             and -11.00 D with less than or equal to 1.00 D refractive cylinder.

          4. The patient must be correctable to 20/25 or better with spectacles.

          5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between
             39.00 and 48.00 D.

          6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

        Exclusion Criteria

          1. The patient has worn rigid gas permeable lenses within the last 30 days or
             polymethylmethacrylate lenses within the last 3 months.

          2. The patient must not be a current successful daily wear user of lotrafilcon A lenses.
             They may have tried lotrafilcon A lenses in the past, but must not have successfully
             worn these lenses for daily wear within the last 12 months.

          3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis),
             immunocompromising disease, connective tissue disease, atopic dermatitis, insulin
             dependent diabetes, or any other systemic disease that in the investigator's opinion
             will affect ocular health.

          4. The patient is taking chronic systemic medications such as corticosteroids,
             antimetabolites, or non-steroidal anti-inflammatory agents or any other medication
             that in the investigator's opinion will affect ocular physiology or study
             participation.

          5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies,
             corneal edema, external ocular infection, iritis, or had any anterior segment surgery.

          6. The patient is taking any ocular medications. If a patient was previously taking any
             ocular medications, the medications must have been discontinued at least 2 weeks prior
             to enrollment.

          7. The patient must have less than or equal to grade 2 on any of the slit lamp
             observations of: upper tarsal papilla, corneal staining, corneal neovascularization,
             conjunctival injection, and lid erythema or scales. Slit lamp findings higher than
             grade 2 bias the patient toward an adverse event and it may be difficult to detect
             true change related to contact lens use.

          8. The patient is pregnant.