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

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Acuvue® Advance™
Other: 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 Names: Acuvue® Advance™
Other: 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 Names: Acuvue® Advance™
Other: 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 Names: Acuvue® Advance™
Other: 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 Names: Acuvue® Advance™
Other: 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 Names: Acuvue® Advance™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ex Vivo Contact Angle	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.	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort	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.	8 hours
Corneal Staining Type	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.	8 hours
Corneal Staining Extent	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.	8 hours

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): June 11, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Multi-purpose solution; Soft Contact lens; Wettability
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: RDG10078 / SILVER