Daily Wear Corneal Infiltrative Event Study (DWCIE)

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Loretta Szczotka-Flynn, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00937105
First received: July 9, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Myopia
Hyperopia
Corneal Infiltrative Events
Device: lotrafilcon A contact lenses
Device: Renu Multiplus
Device: Clear Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Number of Participants Developing a Corneal Inflammatory Event (CIE) [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    Raw number of participants in each solution arm developing CIE over 12 month follow-up period


Secondary Outcome Measures:
  • Number of Participants With CIE Stratified by Microbial Bioburden on Lenses [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 218
Study Start Date: November 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ReNu Multiplus and lotrafilcon A lenses
ReNu Multiplus contact lens care solution
Device: lotrafilcon A contact lenses
FDA approved soft contact lenses
Other Name: Air Optix Night & Day Aqua contact lenses
Device: Renu Multiplus
Active Comparator: Clear Care solution and lotrafilcon A lenses
Clear Care Contact Lens Care Solution
Device: lotrafilcon A contact lenses
FDA approved soft contact lenses
Other Name: Air Optix Night & Day Aqua contact lenses
Device: Clear Care

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937105

Locations
United States, Ohio
Department of Ophthalmology University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Alcon Laboratories
Investigators
Principal Investigator: Loretta Szczotka-Flynn, OD, PhD University Hospital Case Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Loretta Szczotka-Flynn, OD, PhD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00937105     History of Changes
Other Study ID Numbers: 001
Study First Received: July 9, 2009
Results First Received: July 1, 2013
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014