Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens - Full Text View

Sponsor:	University of Waterloo
Collaborator:	Menicon Co., Ltd.
Information provided by:	University of Waterloo
ClinicalTrials.gov Identifier:	NCT00520689

Purpose

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).

Condition	Intervention	Phase
Myopia Hyperopia	Device: Silicone Hydrogel Contact Lens	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment
Official Title:	Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by University of Waterloo:

Primary Outcome Measures:

To see if there are any effects on the cornea when using each contact lens/solution combination. [ Time Frame: Over 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To quantify comfort and vision ratings with each lens/solution combination. [ Time Frame: over 2 days ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	September 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Silicone Hydrogel Contact Lens use of lens over 2 days
2: Active Comparator	Device: Silicone Hydrogel Contact Lens use of lens over 2 days
3: Active Comparator	Device: Silicone Hydrogel Contact Lens use of lens over 2 days
4: Active Comparator	Device: Silicone Hydrogel Contact Lens use of lens over 2 days

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.

Eligibility

Ages Eligible for Study:	17 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520689

Locations

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

Sponsors and Collaborators

University of Waterloo

Menicon Co., Ltd.

Investigators

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

More Information

No publications provided

Responsible Party:	CCLR ( Craig Woods, Research Manager )
Study ID Numbers:	P/264/07/M
Study First Received:	August 22, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00520689 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Hyperopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on February 08, 2010