Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions (SILVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01252134
First received: December 1, 2010
Last updated: May 8, 2012
Last verified: May 2012

December 1, 2010
May 8, 2012
November 2010
February 2011   (final data collection date for primary outcome measure)
Ex Vivo Contact Angle [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
Ex Vivo Lens Wettability [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01252134 on ClinicalTrials.gov Archive Site
  • Subjective Comfort [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.
  • Corneal Staining Type [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.
  • Corneal Staining Extent [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.
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Not Provided
Not Provided
 
Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.

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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Contact Lens Wear
  • Device: Biotrue multipurpose solution
    Contact lens care solution
  • Device: Sauflon Synergi multipurpose solution
    Contact lens care solution
  • Device: OTE Elements multipurpose solution
    Contact lens care solution
  • Device: Silicone hydrogel contact lenses (Acuvue Advance)
    Commercially marketed contact lenses
    Other Name: Acuvue® Advance™
  • Synergi, then Biotrue, then OTE
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
  • Synergi, then OTE, then Biotrue
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
  • Biotrue, then OTE, then Synergi
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
  • Biotrue, then Synergi, then OTE
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
  • OTE, then Biotrue, then Synergi
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
  • OTE, then Synergi, then Biotrue
    Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
    Interventions:
    • Device: Biotrue multipurpose solution
    • Device: Sauflon Synergi multipurpose solution
    • Device: OTE Elements multipurpose solution
    • Device: Silicone hydrogel contact lenses (Acuvue Advance)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age
  • Soft contact lens wear on a daily wear basis
  • Able to wear lenses at least 8 hours
  • Generally healthy with normal ocular health
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Use of additional lens cleaners
  • Known sensitivities to any ingredient in any of the study products
  • History of ocular surgery/trauma within the last 6 months
  • Other protocol-defined exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01252134
RDG10078 / SILVER
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
May 2012

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