Contact Lens Wettability

NCT ID: NCT00349063

Last Updated: 2006-07-19

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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The purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions.

Detailed Description

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Conditions

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Ametropia

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

Soft contact lens multipurpose disinfection regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Has had an oculo-visual examination in the last two years.
2. Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian's permission to participate in the study and has read the Information and Consent Letter for adolescents.

4\. Has read and understood the Information Consent Letter (Appendix II). 5. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.

6\. Has a refractive error that is correctable with the prescription of the available study lenses.

7\. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.

8\. Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered "normal".

Exclusion Criteria

1. Has any systemic disease that may affect ocular health.
2. Is using any systemic or topical medications that may affect ocular health.
3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
4. Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
5. Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
6. Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
7. Has refractive astigmatism of more than 0.75 D.
8. Has corneal distortion resulting from rigid lens wear.
9. Is aphakic.
10. Has undergone corneal refractive surgery.
11. Is participating in any other type of clinical or research study.
12. Is pregnant or lactating.
Minimum Eligible Age

16 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/217/05/L

Identifier Type: -

Identifier Source: org_study_id