Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

NCT ID: NCT00520689

Last Updated: 2009-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Silicone Hydrogel Contact Lens

Intervention Type DEVICE

use of lens over 2 days

2

Group Type ACTIVE_COMPARATOR

Silicone Hydrogel Contact Lens

Intervention Type DEVICE

use of lens over 2 days

3

Group Type ACTIVE_COMPARATOR

Silicone Hydrogel Contact Lens

Intervention Type DEVICE

use of lens over 2 days

4

Group Type ACTIVE_COMPARATOR

Silicone Hydrogel Contact Lens

Intervention Type DEVICE

use of lens over 2 days

Interventions

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Silicone Hydrogel Contact Lens

use of lens over 2 days

Intervention Type DEVICE

Other Intervention Names

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Premio

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menicon Co., Ltd.

INDUSTRY

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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CCLR

Principal Investigators

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Desmond Fonn, M Optom

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Craig Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

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Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P/264/07/M

Identifier Type: -

Identifier Source: org_study_id

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