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Daily Wear Corneal Infiltrative Event Study (DWCIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937105
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Loretta Szczotka-Flynn, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE July 9, 2009
First Posted Date  ICMJE July 10, 2009
Results First Submitted Date  ICMJE July 1, 2013
Results First Posted Date  ICMJE March 10, 2014
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Number of Participants Developing a Corneal Inflammatory Event (CIE) [ Time Frame: up to 1 year ]
Raw number of participants in each solution arm developing CIE over 12 month follow-up period
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
Probability of developing a corneal infiltrative event during daily wear of silicone hydrogel contact lenses. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • Number of Participants With CIE Stratified by Microbial Bioburden on Lenses [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
  • To determine if microbial contamination of lenses and lens cases is associated with the development of a corneal inflammatory event [ Time Frame: 1 year ]
  • To determine if the risk for developing a corneal inflammatory event varies by presence or absence or corneal and/or conjunctival staining induced by lens or solution use. [ Time Frame: 1 year ]
  • To determine if the risk for developing a corneal inflammatory event varies by differing levels of bacterial contamination in combination with corneal and/or conjunctival staining induced by lens or solution use (i.e. interaction). [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Wear Corneal Infiltrative Event Study
Official Title  ICMJE Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Hyperopia
  • Corneal Infiltrative Events
Intervention  ICMJE
  • Device: lotrafilcon A contact lenses
    FDA approved soft contact lenses
    Other Name: Air Optix Night & Day Aqua contact lenses
  • Device: Renu Multiplus
  • Device: Clear Care
Study Arms  ICMJE
  • Active Comparator: ReNu Multiplus and lotrafilcon A lenses
    ReNu Multiplus contact lens care solution
    Interventions:
    • Device: lotrafilcon A contact lenses
    • Device: Renu Multiplus
  • Active Comparator: Clear Care solution and lotrafilcon A lenses
    Clear Care Contact Lens Care Solution
    Interventions:
    • Device: lotrafilcon A contact lenses
    • Device: Clear Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2009)
218
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00937105
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loretta Szczotka-Flynn, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Alcon Research
Investigators  ICMJE
Principal Investigator: Loretta Szczotka-Flynn, OD, PhD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP