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Completed

NCT Number: NCT00520689

Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

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Key information

Age range

17 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is at least 17 years old and has full legal capacity to volunteer
  • Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
  • Is willing and able to follow instructions and maintain the study appointment schedule
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
  • Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
  • Has clear corneas and no active ocular disease
  • Has had an ocular examination in the last two years.
  • Has a functional pair of spectacles
  • Is a current soft lens wearer replacing their lenses at least monthly
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
  • Has astigmatism less than or equal to -1.00DC
  • Agrees to wear the study lenses on a daily wear basis

Exclusion criteria

A person will be excluded from the study if he/she:

  • Has any signs or symptoms of dry eye
  • Has any clinically significant blepharitis
  • Has undergone corneal refractive surgery
  • Is aphakic
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that may affect ocular health
  • Is pregnant or lactating
  • Is participating in any other type of clinical or research study
  • Currently wears daily disposable lenses
  • Currently wears lenses on a continuous or extended wear basis
  • Is unable to successfully wear contact lenses without routinely using rewetting drops

Treatment and study plan

silicone hydrogel contact lens

Device

use of lens over 2 days

Other names: Premio

Primary outcomes

  1. To see if there are any effects on the cornea when using each contact lens/solution combination.

    Time frame: Over 2 days

Secondary outcomes

  1. To quantify comfort and vision ratings with each lens/solution combination.

    Time frame: over 2 days

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Menicon Co., Ltd.

Registry information

Official study title

Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

Acronym: Amethyst

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 24, 2007
Registry last updated
Feb 16, 2009

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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