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Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094743
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : January 25, 2012
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Tracking Information
First Submitted Date  ICMJE March 24, 2010
First Posted Date  ICMJE March 29, 2010
Results First Submitted Date  ICMJE November 7, 2011
Results First Posted Date  ICMJE January 25, 2012
Last Update Posted Date June 19, 2018
Actual Study Start Date  ICMJE February 1, 2010
Actual Primary Completion Date March 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Visual Acuity Monocular [ Time Frame: after 1 week of lens wear ]
    Snellen monocular visual acuity measurement
  • Visual Acuity Binocular [ Time Frame: after 1 week of lens wear ]
    Snellen binocular visual acuity measurement
  • Subjective Assessment of Lens Comfort [ Time Frame: after 1 week of lens wear ]
    Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
  • Subjective Assessment of Quality of Vision [ Time Frame: after 1 week of lens wear ]
    Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Visual Acuity [ Time Frame: measured at visits: initial, 1 week, 2 week ]
Change History Complete list of historical versions of study NCT01094743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Limbal Redness [ Time Frame: after 1 week of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
  • Bulbar Redness [ Time Frame: after 1 week of lens wear ]
    Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
  • Subjective Assessment of Lens Comfort [ Time Frame: 10 minutes after lens insertion at time of initial lens fitting ]
    Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Limbal and Bulbar Redness [ Time Frame: measured at visits: initial, 1 week, 2 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: galyfilcon A prototype lens
    Silicone hydrogel contact lens
  • Device: lotrafilcon B lens
    Silicon Hydrogel contact lens
Study Arms  ICMJE
  • galyfilcon A prototype lens / lotrafilcon B lens
    The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
    Interventions:
    • Device: galyfilcon A prototype lens
    • Device: lotrafilcon B lens
  • lotrafilcon B lens / galyfilcon A prototype lens
    The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
    Interventions:
    • Device: galyfilcon A prototype lens
    • Device: lotrafilcon B lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2010)
52
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
48
Actual Study Completion Date  ICMJE March 1, 2010
Actual Primary Completion Date March 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject must be at least 18 years of age and no more than 39 years of age.
  2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
  3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  4. Any cylinder power must be ≤ -0.75D.
  5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  6. The subject must read and sign the Statement of Informed Consent.
  7. 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 4) 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. Pregnancy or lactation.
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094743
Other Study ID Numbers  ICMJE CR-1636AZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Vision Care, Inc.
Study Sponsor  ICMJE Johnson & Johnson Vision Care, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johnson & Johnson Vision Care, Inc.
Verification Date September 2017

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