Status:

COMPLETED

Contact Lens Wettability

Lead Sponsor:

University of Waterloo

Collaborating Sponsors:

Alcon Research

Conditions:

Ametropia

Eligibility:

All Genders

16+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00349063

Start Date

July 1 2005

Last Update

July 19 2006

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1