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OpenTrials
Completed

NCT Number: NCT00349856

Dispensing Overnight Study in Lenses

The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

About this study

The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Has had an oculo-visual examination in the last 2 years.
  • Is between 18-45 years old and has full legal capacity to volunteer.
  • Has read and understood the Information Consent Letter
  • Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
  • Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
  • Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
  • Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
  • Has refractive astigmatism of <= 1.00 diopters
  • Has clear corneas and ocular clinical findings considered to be "normal".

Exclusion criteria

  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
  • Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
  • Has never worn contact lenses before.
  • 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.

Treatment and study plan

Biofinity

Device

Soft contact lens

Other names: Purevision

Primary outcomes

  1. The primary objective of this trial is to assess safety of the investigational

    Time frame: study visits, three monthly

Secondary outcomes

  1. The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.

    Time frame: study visits, three monthly

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Cooper Companies

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2006
Registry last updated
Feb 18, 2009

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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