Clincosm LogoSign in Get a demo

Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00639353
Collaborator
Johnson & Johnson (Industry)
102
Enrollment
10
Locations
2
Arms
10.2
Patients Per Site

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.

Condition or Disease Intervention/Treatment Phase
  • Device: senofilcon A toric soft contact lens
  • Device: senofilcon A sphere soft contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: spherical contact lens

Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks

Device: senofilcon A sphere soft contact lens
contact lens
Other Names:
  • ACUVUE OASYS

    		•
    Experimental: toric contact lens

    Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks

    Device: senofilcon A toric soft contact lens
    contact lens
    Other Names:
  • ACUVUE OASYS for Astigmatism

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Subject-reported satisfaction for vision [After 2 weeks of lens wear]

      Scale of 0 to 100, were 0=extremely poor and 100=Excellent

    2. Subject-reported satisfaction for comfort. [After 2 weeks of lens wear]

      Scale of 0 to 100, were 0=extremely poor and 100=Excellent

    Secondary Outcome Measures

    1. Subject preference for lens type. [After 2 weeks of lens wear.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)

    2. The subject has signed an informed consent with his/her own judgement for participation in the study.

    3. The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.

    Exclusion Criteria:

    1. The subject has any ocular or systemic allergies that interfere with contact lens wear.

    2. The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.

    3. The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.

    4. The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.

    5. The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.

    6. The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.

    7. The subject has ocular infection.

    8. The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).

    9. The subject has corneal distortion resulting from previous experience of hard contact lens wear.

    10. The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.

    11. The subject has diabetes, as far as known to the subject.

    12. The subject is pregnant or in the lactation period, as far as known to the subject.

    13. The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).

    14. The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.

    15. The subject is a wearer of hard contact lenses (including rigid gas permeable).

    16. The subject is exposed to a dry environment on a constant basis.

    17. The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.

    18. The subject is unable to follow the principal investigator's instructions.

    19. The subject is unable to follow lens hygiene procedures necessary for contact lens wear.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shioya eye clinic Fukushimashi Fukushima Japan
    2 Takahashi eye clinic Odawarashi Kanagawa Japan
    3 Kodama eye clinic Jyoyoshi Kyoto Japan
    4 Inaba eye clinic Osakashi Osaka Japan
    5 Iwasaki eye clinic Osakashi Osaka Japan
    6 Watanabe eye clinic Osakashi Osaka Japan
    7 Sakura eye clinic Shizuokashi Shizuoka Japan
    8 Kajita eye clinic Minatoku Tokyo Japan
    9 Dogenzakaitoi eye clinic Shibuyaku Tokyo Japan
    10 Ueda eye clinic Shimonosekishi Yamaguchi Japan

    Sponsors and Collaborators

    • Johnson & Johnson Vision Care, Inc.
    • Johnson & Johnson

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Vision Care, Inc.
    ClinicalTrials.gov Identifier:
    NCT00639353
    Other Study ID Numbers:
    • CR-0804
    First Posted:
    Mar 20, 2008
    Last Update Posted:
    Oct 29, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Astigmatism
    Refractive Errors

    Study Results

    No Results Posted as of Oct 29, 2014