Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01244893
First received: November 18, 2010
Last updated: February 6, 2014
Last verified: February 2014

November 18, 2010
February 6, 2014
October 2010
November 2010   (final data collection date for primary outcome measure)
Visual Acuity (VA) [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.
Visual Acuity [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01244893 on ClinicalTrials.gov Archive Site
  • Corneal Staining [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
    Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
  • Limbal Redness [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
    Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
  • Bulbar Redness [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
    Scale of 0 increasing to 4. 0=None, 4=Severe Redness
  • Corneal staining [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
  • Limbal redness [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
  • Bulbar redness [ Time Frame: 6-8 days after lens wear ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
Not Provided

The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myopia
  • Device: Acuvue Advance Plus prePQ
    silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
  • Device: Acuvue Advance Plus postPQ
    silicone hydrogel contact lens manufactured after equipment process qualification activities.
  • Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ
    Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.
    Interventions:
    • Device: Acuvue Advance Plus prePQ
    • Device: Acuvue Advance Plus postPQ
  • Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ
    Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.
    Interventions:
    • Device: Acuvue Advance Plus prePQ
    • Device: Acuvue Advance Plus postPQ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
Not Provided
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject must be at least 18 years of age and no more than 39 years of age.
  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Both
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01244893
CR-1636BI
Not Provided
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP