Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01100411
Collaborator
(none)
35
1
6
4
8.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate changes in contact lens geometry after lens wear

Condition or Disease Intervention/Treatment Phase
  • Device: Air Optix Aqua
  • Device: Biofinity
  • Device: Proclear
  • Device: Acuvue Oasys
  • Device: Acuvue 2
  • Device: Purevision
N/A

Detailed Description

The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Air Optix Aqua

Contact lens material: Lotrafilcon A

Device: Air Optix Aqua
Contact lens material: Lotrafilcon A
Other Names:
  • Air Optix
  • Active Comparator: Biofinity

    Contact lens material: Comfilcon A

    Device: Biofinity
    Contact lens material: Comfilcon A
    Other Names:
  • CV Biofininty
  • Active Comparator: Proclear

    Contact lens material: Omafilcon A

    Device: Proclear
    Contact lens material: Omafilcon A
    Other Names:
  • Proclear Compatibles
  • Active Comparator: Acuvue Oasys

    Contact lens material: Senofilcon A

    Device: Acuvue Oasys
    Contact lens material: Senofilcon A
    Other Names:
  • Oasys
  • Active Comparator: Acuvue 2

    Contact lens material: Etafilcon A

    Device: Acuvue 2
    Contact lens material: Etafilcon A
    Other Names:
  • AV 2
  • Active Comparator: Purevision

    Contact lens material: Balafilcon A

    Device: Purevision
    Contact lens material: Balafilcon A
    Other Names:
  • PV
  • Outcome Measures

    Primary Outcome Measures

    1. Lens Geometry [1 week]

    Secondary Outcome Measures

    1. Corneal Shape [1 week]

    2. Conjunctival Staining [1 week]

      The conjunctival staining

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

    • Be at least 18 years old;

    • Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;

    • Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;

    • Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;

    • Be experienced at wearing contact lenses.

    Exclusion Criteria:
    • • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

    • Any systemic disease that adversely affects ocular health

    • An active corneal infection or any active ocular disease that would affect wearing of contact lenses;

    • Use of any topical ocular medication during trial with the exception of saline drops ;

    • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance

    • Eye surgery within 12 weeks immediately prior to enrolment for this trial;

    • Previous corneal refractive surgery;

    • Contraindications to contact lens wear;

    • Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;

    • Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);

    • Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute for Eye Research Sydney New South Wales Australia 2052

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Chair: Alcon Call Center, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT01100411
    Other Study ID Numbers:
    • M-10-01
    First Posted:
    Apr 9, 2010
    Last Update Posted:
    Jul 18, 2012
    Last Verified:
    Nov 1, 2011
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2012