Daily Wear Corneal Infiltrative Event Study

Phase 4

Completed

• Conditions: Myopia; Corneal Infiltrative Events; Hyperopia
• Interventions: Device: lotrafilcon A contact lenses; Device: Renu Multiplus; Device: Clear Care

• Registration Number: NCT00937105
• Lead Sponsor: University Hospitals Cleveland Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Study Start: 2009-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-07-01
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Results First Posted: 2014-03-10
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReNu Multiplus and lotrafilcon A lenses	Renu Multiplus	ReNu Multiplus contact lens care solution
ReNu Multiplus and lotrafilcon A lenses	lotrafilcon A contact lenses	ReNu Multiplus contact lens care solution
Clear Care solution and lotrafilcon A lenses	lotrafilcon A contact lenses	Clear Care Contact Lens Care Solution
Clear Care solution and lotrafilcon A lenses	Clear Care	Clear Care Contact Lens Care Solution

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With CIE Stratified by Microbial Bioburden on Lenses	up to 1 year	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
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.	up to 1 year	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
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases	up to 1 year	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
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins	up to 1 year	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
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins	up to 1 year	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

Trial Locations

Locations (1)

Department of Ophthalmology University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States