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Status:

COMPLETED

Daily Wear Corneal Infiltrative Event Study

Lead Sponsor:

University Hospitals Cleveland Medical Center

Collaborating Sponsors:

Alcon Research

Conditions:

Myopia

Hyperopia

Eligibility:

All Genders

15+ years

Phase:

PHASE4

Brief 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 mo...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • The patient must be at least 15 years old.
  • The patient must be free of any anterior segment disorders.
  • 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.
  • The patient must be correctable to 20/25 or better with spectacles.
  • Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
  • Can be successfully fit with lotrafilcon A lenses at the enrollment visit.
  • Exclusion Criteria
  • The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • The patient is pregnant.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2012

    Estimated Enrollment :

    218 Patients enrolled

    Trial Details

    Trial ID

    NCT00937105

    Start Date

    November 1 2009

    End Date

    February 1 2012

    Last Update

    March 10 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Department of Ophthalmology University Hospitals Case Medical Center

    Cleveland, Ohio, United States, 44106