Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

Study Overview
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Brief Summary
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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.

Official Title
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The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

Conditions
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Contact Lens Wear

Intervention / Treatment
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* Device: Biotrue multipurpose solution
* Device: Sauflon Synergi multipurpose solution
* Device: OTE Elements multipurpose solution
* Device: Silicone hydrogel contact lenses (Acuvue Advance)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Synergi, then Biotrue, then OTE<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|
| Other: Synergi, then OTE, then Biotrue<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|
| Other: Biotrue, then OTE, then Synergi<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|
| Other: Biotrue, then Synergi, then OTE<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|
| Other: OTE, then Biotrue, then Synergi<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|
| Other: OTE, then Synergi, then Biotrue<br>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<br>* Contact lens care solution<br>Device: Sauflon Synergi multipurpose solution<br>* Contact lens care solution<br>Device: OTE Elements multipurpose solution<br>* Contact lens care solution<br>Device: Silicone hydrogel contact lenses (Acuvue Advance)<br>* Commercially marketed contact lenses<br>* Other names: Acuvue® Advance™;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft Contact lens, Multi-purpose solution, Wettability