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Comparison of Two Marketed Silicone Hydrogel Lenses

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Lotrafilcon B contact lenses Device: Samfilcon A contact lenses Device: Hydrogen peroxide solution Device: Saline solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495948


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Trial Manager, Vision Care, GCRA Alcon, A Novartis Division
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02495948    
Other Study ID Numbers: CLA560-P001
First Posted: July 13, 2015    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: December 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases
Hydrogen Peroxide
 Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents