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Contact Lens Wettability
This study has been completed.
Sponsors and Collaborators: University of Waterloo
Alcon Research
Information provided by: University of Waterloo
ClinicalTrials.gov Identifier: NCT00349063
  Purpose

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


Condition Intervention Phase
Ametropia
Device: soft contact lens
Drug: Soft contact lens multipurpose disinfection regimen
Phase IV

MedlinePlus related topics: Eye Wear
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Official Title: The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability

Further study details as provided by University of Waterloo:

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.

Estimated Enrollment: 55
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349063

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Craig Woods, PhD University of Waterloo
Principal Investigator: Desmond Fonn, MOptom University of Waterloo
  More Information

Study ID Numbers: P/217/05/L
Study First Received: July 4, 2006
Last Updated: July 17, 2006
ClinicalTrials.gov Identifier: NCT00349063  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009