Effects of Contact Lens Care Regimens on the Corneal Epithelium

NCT ID: NCT00349882

Last Updated: 2006-07-10

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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soft contact lens

Intervention Type DEVICE

Marketed multipurpose disinfection regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Is at least 18 years old and has full legal capacity to volunteer.
2. Has read, understood and signed an Information Consent Letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual 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 2 years.
8. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.

An ineligible contact lens wearer is one who:
9. Responds positively to points 1 to 7 above.
10. Has a distance contact lens prescription between -0.50D and -9.00 D.
11. Has astigmatism less than or equal to -1.00D cyl.
12. Currently wears silicone hydrogel contact lenses successfully.
13. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.

Exclusion Criteria

1. Has undergone corneal refractive surgery.
2. Is aphakic.
3. Has any active ocular disease.
4. Has any systemic disease affecting ocular health.
5. Is using any systemic or topical medications that may affect ocular health.
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
7. Is pregnant or lactating.
8. Is participating in any other type of clinical or research study.

An ineligible contact lens wearer is one who:
10. Has known sensitivity to the contact lens care solutions used in the study.
11. Has ocular or systemic allergies that could adversely affect contact lens wear.
12. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
13. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role lead

Principal Investigators

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Craig Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Desmond Fonn, MOptom

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/216/05/L

Identifier Type: -

Identifier Source: org_study_id