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

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ClinicalTrials.gov Identifier: NCT01252134
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contact Lens Wear Device: Biotrue multipurpose solution Device: Sauflon Synergi multipurpose solution Device: OTE Elements multipurpose solution Device: Silicone hydrogel contact lenses (Acuvue Advance) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
Study Start Date : November 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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.
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 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.
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™
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.
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™
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.
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™
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.
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™
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.
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™



Primary Outcome Measures :
  1. Ex Vivo Contact Angle [ Time Frame: 8 hours ]
    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.


Secondary Outcome Measures :
  1. Subjective Comfort [ Time Frame: 8 hours ]
    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.

  2. Corneal Staining Type [ Time Frame: 8 hours ]
    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.

  3. Corneal Staining Extent [ Time Frame: 8 hours ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01252134     History of Changes
Other Study ID Numbers: RDG10078 / SILVER
First Posted: December 2, 2010    Key Record Dates
Results First Posted: June 11, 2012
Last Update Posted: June 11, 2012
Last Verified: May 2012

Keywords provided by Alcon Research:
Soft Contact lens
Multi-purpose solution
Wettability

Additional relevant MeSH terms:
Pharmaceutical Solutions