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Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

Sponsor
CIBA VISION (Industry)
Overall Status
Completed
CT.gov ID
NCT01446835
Collaborator
(none)
151
Enrollment
1
Location
2
Arms
1
Duration (Months)
148.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.

Condition or Disease Intervention/Treatment Phase
  • Device: nelfilcon A contact lens with print
  • Device: etafilcon A contact lens with print
 N/A

Detailed Description

Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: nelfilcon A

Nelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes.

Device: nelfilcon A contact lens with print
Investigational spherical contact lens
Active Comparator: etafilcon A

Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear.

Device: etafilcon A contact lens with print
Commercially marketed (Singapore) spherical contact lens
Other Names:
  • 1-DAY ACUVUE DEFINE Vivid Style

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cosmetic Appearance Preference [After 20 minutes of wear]

      Participant will be asked on a questionnaire, "Which lens do you prefer for looking more natural?" Subject will record on the questionnaire, "Left lens," "Right lens," or "No preference."

    Secondary Outcome Measures

    1. Lens Centration [After insertion and before 20 minutes of wear]

      Investigator will assess lens centration using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens centration will be graded on a 5-point scale, with 0 being centered and 4 being severe decentration with corneal exposure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female between 18 and 30 years of age (inclusive).

    • If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.

    • Sign written Informed Consent.

    • Chinese, Japanese, or Korean descent.

    • Brown eye color.

    • Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D).

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Eye injury or surgery within twelve weeks prior to enrollment.

    • Pre-existing ocular irritation that would preclude contact lens fitting.

    • Currently enrolled in any clinical ophthalmic trial.

    • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.

    • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore Polytechnic Spoc W115 Singapore 139651

    Sponsors and Collaborators

    • CIBA VISION

    Investigators

    • Principal Investigator: Danny Sim Chek Hoo, B Optom (Hons), Singapore Polytechnic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01446835
    Other Study ID Numbers:
    • P-418-C-003
    First Posted:
    Oct 5, 2011
    Last Update Posted:
    Jun 28, 2012
    Last Verified:
    Jan 1, 2012

    Study Results

    No Results Posted as of Jun 28, 2012