Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Marketed Silicone Hydrogel Lenses

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: NCT02495948
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : October 19, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE July 9, 2015
First Posted Date  ICMJE July 13, 2015
Results First Submitted Date  ICMJE August 25, 2016
Results First Posted Date  ICMJE October 19, 2016
Last Update Posted Date December 28, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear [ Time Frame: Day 30, each product ]
The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2015)
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear [ Time Frame: Day 31 ]
The contact lens will be removed from the eye. Cholesterol deposits will be extracted and measured in micrograms per lens.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Marketed Silicone Hydrogel Lenses
Official Title  ICMJE One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
Brief Summary The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Condition  ICMJE Refractive Error
Intervention  ICMJE
  • Device: Lotrafilcon B contact lenses
    Other Name: AIR OPTIX® AQUA
  • Device: Samfilcon A contact lenses
    Other Name: Bausch + Lomb ULTRA
  • Device: Hydrogen peroxide solution
    Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
    Other Name: CLEAR CARE®
  • Device: Saline solution
    Used for rinsing contact lenses, as needed
    Other Name: SENSITIVE EYES® PLUS
Study Arms  ICMJE
  • AOA then ULTRA
    Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
    Interventions:
    • Device: Lotrafilcon B contact lenses
    • Device: Samfilcon A contact lenses
    • Device: Hydrogen peroxide solution
    • Device: Saline solution
  • ULTRA then AOA
    Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
    Interventions:
    • Device: Lotrafilcon B contact lenses
    • Device: Samfilcon A contact lenses
    • Device: Hydrogen peroxide solution
    • Device: Saline solution
Publications * Not Provided

*   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: August 18, 2015)
168
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2015)
150
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sign informed consent document;
  • Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
  • Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
  • Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
  • History of herpetic keratitis, corneal surgery or irregular cornea;
  • Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02495948
Other Study ID Numbers  ICMJE CLA560-P001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Manager, Vision Care, GCRA Alcon, A Novartis Division
PRS Account Alcon Research
Verification Date November 2016

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