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OpenTrials
Completed

NCT Number: NCT00349063

Contact Lens Wettability

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

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Key information

Age range

16 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

  • 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.
  • 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.
  • Has a refractive error that is correctable with the prescription of the available study lenses.
  • Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
  • Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered "normal".

Exclusion criteria

  • 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.

Treatment and study plan

Soft contact lens

Device

Soft contact lens multipurpose disinfection regimen

Drug

Primary outcomes

  1. To investigate the impact of wearing time and contact lens care solutions on in

  2. vivo and ex vivo wettability of currently marketed contact lenses

Secondary outcomes

  1. To determine if there is a correlation between in vivo wettability, ex vivo

  2. wettability and in-eye comfort. To determine if comfort and wettability vary

  3. between symptomatic and asymptomatic lens wearers.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Official study title

The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability

Important dates

Study start
2005
First posted
Jul 6, 2006
Registry last updated
Jul 19, 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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