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
  Purpose

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).


Condition Intervention
Myopia
Device: Acuvue Advance Plus prePQ
Device: Acuvue Advance Plus postPQ

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 44
Study Start Date: October 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244893

Locations
United States, Ohio
Powell, Ohio, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Virginia
Salem, Virginia, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01244893     History of Changes
Other Study ID Numbers: CR-1636BI
Study First Received: November 18, 2010
Results First Received: August 29, 2013
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014