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OpenTrials
Completed

NCT Number: NCT01252134

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.

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Key information

Conditions

Contact Lens Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biotrue multipurpose solution

Device

Contact lens care solution

Sauflon Synergi multipurpose solution

Device

Contact lens care solution

OTE Elements multipurpose solution

Device

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Device

Commercially marketed contact lenses

Other names: Acuvue® Advance™

Primary outcomes

  1. Ex Vivo Contact Angle

    Time frame: 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 outcomes

  1. Subjective Comfort

    Time frame: 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.

  2. Corneal Staining Type

    Time frame: 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.

  3. Corneal Staining Extent

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Acronym: SILVER

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2010
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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