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OpenTrials
Completed

NCT Number: NCT00349882

Effects of Contact Lens Care Regimens on the Corneal Epithelium

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.
  • Has a distance contact lens prescription between -0.50D and -9.00 D.
  • Has astigmatism less than or equal to -1.00D cyl.
  • Currently wears silicone hydrogel contact lenses successfully.
  • Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.

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.
  • Has known sensitivity to the contact lens care solutions used in the study.
  • Has ocular or systemic allergies that could adversely affect contact lens wear.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.

Treatment and study plan

Soft contact lens

Device

Marketed multipurpose disinfection regimen

Drug

Primary outcomes

  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 outcomes

  1. The secondary outcome measure of this study is to compare the subjective and

  2. objective responses between two different contact lens care solutions.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2005
First posted
Jul 10, 2006
Registry last updated
Jul 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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