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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014