Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens (Amethyst)

February 12, 2009 updated by: University of Waterloo

Multipurpose Solution Compatibility With a Silicone Hydrogel 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Names:
  • Premio
Active Comparator: 1
Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Names:
  • Premio
Active Comparator: 3
Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Names:
  • Premio
Active Comparator: 4
Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Names:
  • Premio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To see if there are any effects on the cornea when using each contact lens/solution combination.
Time Frame: Over 2 days
Over 2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To quantify comfort and vision ratings with each lens/solution combination.
Time Frame: over 2 days
over 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Waterloo

Collaborators

Menicon Co., Ltd.

Investigators

  • Principal Investigator: Craig Woods, PhD, University of Waterloo
  • Principal Investigator: Desmond Fonn, M Optom, University of Waterloo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/264/07/M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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