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Effects of Contact Lens Care Regimens on the Corneal Epithelium

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ClinicalTrials.gov Identifier: NCT00349882
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : July 10, 2006
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Device: soft contact lens Drug: Marketed multipurpose disinfection regimen Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Contact Lens Care Regimens on the Corneal Epithelium
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00349882     History of Changes
Other Study ID Numbers: P/216/05/L
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: July 10, 2006
Last Verified: July 2006