Daily Wear Corneal Infiltrative Event Study (DWCIE)

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Myopia; Corneal Infiltrative Events; Hyperopia

Treatments: Device: Clear Care; Device: lotrafilcon A contact lenses; Device: Renu Multiplus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00937105

001

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

ReNu Multiplus and lotrafilcon A lenses

Active Comparator group

Description:

ReNu Multiplus contact lens care solution

Treatment:

Device: Renu Multiplus

Device: lotrafilcon A contact lenses

Clear Care solution and lotrafilcon A lenses

Active Comparator group

Description:

Clear Care Contact Lens Care Solution

Treatment:

Device: Clear Care

Device: lotrafilcon A contact lenses