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Dispensing Evaluation of 1-Day ACUVUE® DEFINE™ With LACREON™ for Light Eye Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01180777
First received: August 3, 2010
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the 1∙DAY ACUVUE® DEFINE™ with LACREON™ for Light Eyes lenses.


Condition Intervention
Myopia
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Device: 1-Day ACUVUE® Moist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dispensing Evaluation of 1-Day ACUVUE® DEFINE™ With LACREON™ for Light Eye Lenses

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens fit acceptance [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
    Determined by the eye doctor under slit lamp evaluation.


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
    Visual acuity will be measured binocular using snellen vision chart.

  • Corneal staining [ Time Frame: after 1 week of wear ] [ Designated as safety issue: No ]
    The investigator will assess corneal staining by use of a slit lamp.

  • Overall comfort assessment [ Time Frame: after 1 week of wear ] [ Designated as safety issue: No ]
    The subject will answer a survey regarding comfort.

  • Lens handling assessment [ Time Frame: after 1 week of wear ] [ Designated as safety issue: No ]
    The subject will answer a survey regarding lens handling.


Enrollment: 80
Study Start Date: July 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ZBC/PBC/Moist
1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)worn first period. 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC) worn second period. 1-Day ACUVUE® Moist worn third period.
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.
Active Comparator: ZBC/Moist/PBC
1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)worn first period. 1-Day ACUVUE® Moist worn second period. 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC) worn third period.
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.
Active Comparator: PBC/ZBC/Moist
1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses(PBC)worn first period.1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses(PBC)worn second period. 1-Day ACUVUE® Moist worn third period.
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.
Active Comparator: PBC/Moist/ZBC
1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)worn first period. 1-Day ACUVUE® Moist worn second period. 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC) worn third period.
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.
Active Comparator: Moist/ZBZ/PBC
1-Day ACUVUE® Moist worn first period.1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)worn second period. 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC) worn third period.
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.
Active Comparator: Moist/PBC/ZBC
1-Day ACUVUE® Moist worn first period.1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)worn second period. 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
 Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (ZBC)
Daily wear contact lens
Device: 1-Day ACUVUE® DEFINE™ with LACREON™ for light eye lenses (PBC)
Daily wear contact lens.
Device: 1-Day ACUVUE® Moist
Daily wear contact lens.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must be at least 18 years of age and less than 40 years of age.
  2. The subject must be a light eye Caucasian female habitual soft contact lens wearer.
  3. The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
  4. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  5. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  6. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  7. Any cylinder power must be ≤ -0.75D.
  8. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  9. The subject must have normal eyes (no ocular medications or ocular infection of any type).
  10. The subject must read and sign the Statement of Informed Consent.
  11. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
  2. Systemic disease or use of medication which might interfere with contact lens wear.
  3. Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Any color deficiencies - to the best of the subject's knowledge.
  8. Pregnancy or lactation.
  9. Diabetes.
  10. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  11. Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180777

Locations
United States, California
Cupertino, California, United States, 95014
Los Angeles, California, United States, 90049
San Jose, California, United States, 95131
United States, Florida
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32256
Orlando, Florida, United States, 32792
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01180777     History of Changes
Other Study ID Numbers: CR-1579AP
Study First Received: August 3, 2010
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013