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Contact Lens Wettability

Primary Purpose

Ametropia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
soft contact lens
Soft contact lens multipurpose disinfection regimen
Sponsored by
University of Waterloo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ametropia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: Has had an oculo-visual examination in the last two years. 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: Has any systemic disease that may affect ocular health. Is using any systemic or topical medications that may affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses. Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities. Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant. Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable. Has refractive astigmatism of more than 0.75 D. Has corneal distortion resulting from rigid lens wear. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of clinical or research study. Is pregnant or lactating.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Outcomes

Primary Outcome Measures

To investigate the impact of wearing time and contact lens care solutions on in
vivo and ex vivo wettability of currently marketed contact lenses

Secondary Outcome Measures

To determine if there is a correlation between in vivo wettability, ex vivo
wettability and in-eye comfort. To determine if comfort and wettability vary
between symptomatic and asymptomatic lens wearers.

Full Information

First Posted
July 4, 2006
Last Updated
July 17, 2006
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00349063
Brief Title
Contact Lens Wettability
Official Title
The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Alcon Research

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
soft contact lens
Intervention Type
Drug
Intervention Name(s)
Soft contact lens multipurpose disinfection regimen
Primary Outcome Measure Information:
Title
To investigate the impact of wearing time and contact lens care solutions on in
Title
vivo and ex vivo wettability of currently marketed contact lenses
Secondary Outcome Measure Information:
Title
To determine if there is a correlation between in vivo wettability, ex vivo
Title
wettability and in-eye comfort. To determine if comfort and wettability vary
Title
between symptomatic and asymptomatic lens wearers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Eligibility Criteria
Inclusion Criteria: Has had an oculo-visual examination in the last two years. 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: Has any systemic disease that may affect ocular health. Is using any systemic or topical medications that may affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses. Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities. Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant. Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable. Has refractive astigmatism of more than 0.75 D. Has corneal distortion resulting from rigid lens wear. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of clinical or research study. Is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Woods, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Contact Lens Wettability

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