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
  Purpose

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 Intervention
Contact Lens Wear
Device: Biotrue multipurpose solution
Device: Sauflon Synergi multipurpose solution
Device: OTE Elements multipurpose solution
Device: Silicone hydrogel contact lenses (Acuvue Advance)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01252134     History of Changes
Other Study ID Numbers: RDG10078 / SILVER
Study First Received: December 1, 2010
Results First Received: May 8, 2012
Last Updated: May 8, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 17, 2014