Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

Not Applicable

Completed

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

• Registration Number: NCT01252134
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-05
• Results First Submitted: 2012-05-08
• Results First Submitted QC: 2012-05-08
• Last Update Submitted: 2012-05-08
• Results First Posted: 2012-06-11
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Synergi, then Biotrue, then OTE	Biotrue multipurpose solution	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.
Synergi, then Biotrue, then OTE	Sauflon Synergi multipurpose solution	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.
Synergi, then Biotrue, then OTE	OTE Elements multipurpose solution	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.
Synergi, then Biotrue, then OTE	Silicone hydrogel contact lenses (Acuvue Advance)	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.
Synergi, then OTE, then Biotrue	Biotrue multipurpose solution	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.
Synergi, then OTE, then Biotrue	Sauflon Synergi multipurpose solution	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.
Synergi, then OTE, then Biotrue	OTE Elements multipurpose solution	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.
Synergi, then OTE, then Biotrue	Silicone hydrogel contact lenses (Acuvue Advance)	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.
Biotrue, then OTE, then Synergi	Biotrue multipurpose solution	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.
Biotrue, then OTE, then Synergi	Sauflon Synergi multipurpose solution	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.
Biotrue, then OTE, then Synergi	OTE Elements multipurpose solution	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.
Biotrue, then OTE, then Synergi	Silicone hydrogel contact lenses (Acuvue Advance)	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.
OTE, then Synergi, then Biotrue	Biotrue multipurpose solution	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.
Biotrue, then Synergi, then OTE	Biotrue multipurpose solution	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.
Biotrue, then Synergi, then OTE	Sauflon Synergi multipurpose solution	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.
Biotrue, then Synergi, then OTE	OTE Elements multipurpose solution	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.
Biotrue, then Synergi, then OTE	Silicone hydrogel contact lenses (Acuvue Advance)	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.
OTE, then Biotrue, then Synergi	Biotrue multipurpose solution	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.
OTE, then Biotrue, then Synergi	Sauflon Synergi multipurpose solution	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.
OTE, then Biotrue, then Synergi	OTE Elements multipurpose solution	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.
OTE, then Biotrue, then Synergi	Silicone hydrogel contact lenses (Acuvue Advance)	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.
OTE, then Synergi, then Biotrue	Sauflon Synergi multipurpose solution	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.
OTE, then Synergi, then Biotrue	OTE Elements multipurpose solution	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.
OTE, then Synergi, then Biotrue	Silicone hydrogel contact lenses (Acuvue Advance)	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.

Primary Outcome Measures

Name	Time	Method
Ex Vivo Contact Angle	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

Name	Time	Method
Subjective Comfort	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.
Corneal Staining Type	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.
Corneal Staining Extent	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.