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CompletedNCT00349856Updated Feb 18, 2009

Dispensing Overnight Study in Lenses

A Phase 3 interventional study of Biofinity in Myopia, sponsored by University of Waterloo. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-18.

Sponsored by University of Waterloo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

University of Waterloo is the lead sponsor of 90 studies on the registry; 8 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Has any systemic disease affecting ocular health.
  2. Is using any systemic or topical medications that will affect ocular health.
  3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
  5. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
  6. Has never worn contact lenses before.
  7. Has corneal distortion resulting from rigid lens wear.
  8. Is aphakic.
  9. Has undergone corneal refractive surgery.
  10. Is participating in any other type of clinical or research study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    1

    Device: Biofinity

Interventions

  • DeviceBiofinity

    Soft contact lens

    Also known as: Purevision

06

What researchers measure

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

07

Study locations

1 site
  • Centre for Contact Lens Research, University of Waterloo
    Waterloo, Ontario N2L3G1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00349856
Lead sponsor
University of Waterloo
Collaborators
Cooper Companies
First posted
Jul 10, 2006
Start date
Jan 2005
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Feb 18, 2009

Study contacts

Desmond Fonn, MOptom
principal investigator · Centre for Contact Lens Research, University of Waterloo.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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