Daily Wear Corneal Infiltrative Event Study

Study Overview
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Brief Summary
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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.

Official Title
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Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

Conditions
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Myopia, Hyperopia, Corneal Infiltrative Events

Intervention / Treatment
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* Device: lotrafilcon A contact lenses
* Device: Renu Multiplus
* Device: Clear Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReNu Multiplus and lotrafilcon A lenses<br>ReNu Multiplus contact lens care solution | Device: lotrafilcon A contact lenses<br>* FDA approved soft contact lenses<br>* Other names: Air Optix Night & Day Aqua contact lenses;Device: Renu Multiplus<br> <br> |
| Active Comparator: Clear Care solution and lotrafilcon A lenses<br>Clear Care Contact Lens Care Solution | Device: lotrafilcon A contact lenses<br>* FDA approved soft contact lenses<br>* Other names: Air Optix Night & Day Aqua contact lenses;Device: Clear Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Developing a Corneal Inflammatory Event (CIE) | Raw number of participants in each solution arm developing CIE over 12 month follow-up period | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With CIE Stratified by Microbial Bioburden on Lenses | Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses | up to 1 year | 
| Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use. | Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones | up to 1 year | 
| Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases | Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora | up to 1 year | 
| Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins | Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids | up to 1 year | 
| Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins | Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids | up to 1 year |