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Dispensing Overnight Study in Lenses

Sponsor
University of Waterloo (Other)
Overall Status
Completed
CT.gov ID
NCT00349856
Collaborator
Cooper Companies (Industry)
40
Enrollment
1
Location
1
Arm
37.9
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biofinity
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Dispensing Overnight Study in Lenses
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Device: Biofinity
Soft contact lens
Other Names:
  • Purevision

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary objective of this trial is to assess safety of the investigational [study visits, three monthly]

    Secondary Outcome Measures

    1. The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses. [study visits, three monthly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    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:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Contact Lens Research, University of Waterloo Waterloo Ontario Canada N2L3G1

    Sponsors and Collaborators

    • University of Waterloo
    • Cooper Companies

    Investigators

    • Principal Investigator: Desmond Fonn, MOptom, Centre for Contact Lens Research, University of Waterloo.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00349856
    Other Study ID Numbers:
    • P/209/04/O
    First Posted:
    Jul 10, 2006
    Last Update Posted:
    Feb 18, 2009
    Last Verified:
    Feb 1, 2009
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Feb 18, 2009