Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions - Full Text View

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:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

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 May 16, 2013

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