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Clinical Trials/NCT00349882
NCT00349882
Completed
Phase 4

Effects of Contact Lens Care Regimens on the Corneal Epithelium

University of Waterloo1 site in 1 country30 target enrollmentJune 2005

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Myopia
Sponsor
University of Waterloo
Enrollment
30
Locations
1
Primary Endpoint
The primary outcome measure of this study is to investigate the effects of two
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Is at least 18 years old and has full legal capacity to volunteer.
  • Has read, understood and signed an Information Consent Letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual correction.
  • Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last 2 years.
  • 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:
  • Responds positively to points 1 to 7 above.

Exclusion Criteria

  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • An ineligible contact lens wearer is one who:
  • Responds positively to any of points 1 to 8 above for exclusion criteria.

Outcomes

Primary Outcomes

The primary outcome measure of this study is to investigate the effects of two

different contact lens care solutions on the cornea.

Secondary Outcomes

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

Study Sites (1)

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