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Effects of Contact Lens Care Regimens on the Corneal Epithelium

This study has been completed.

Sponsors and Collaborators: University of Waterloo
Alcon Research
Information provided by: University of Waterloo
ClinicalTrials.gov Identifier: NCT00349882
  Purpose

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.


Condition Intervention Phase
Myopia
Device: soft contact lens
Drug: Marketed multipurpose disinfection regimen
Phase IV

MedlinePlus related topics:   Eye Wear   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:   Effects of Contact Lens Care Regimens on the Corneal Epithelium

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • The primary outcome measure of this study is to investigate the effects of two
  • different contact lens care solutions on the cornea.

Secondary Outcome Measures:
  • The secondary outcome measure of this study is to compare the subjective and
  • objective responses between two different contact lens care solutions.

Estimated Enrollment:   30
Study Start Date:   June 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

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:

  9. Responds positively to any of points 1 to 8 above for exclusion criteria.
  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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349882

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/216/05/L
First Received:   July 5, 2006
Last Updated:   July 5, 2006
ClinicalTrials.gov Identifier:   NCT00349882
Health Authority:   Canada: Health Canada

Study placed in the following topic categories:
Myopia

ClinicalTrials.gov processed this record on October 10, 2008




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