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Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

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: NCT00762502
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : November 25, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE March 28, 2014
Results First Posted Date  ICMJE November 25, 2014
Last Update Posted Date June 19, 2018
Study Start Date  ICMJE June 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
  • Corneal Staining [ Time Frame: at 3 months of lens wear (period 1) ]
    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
  • Limbal Redness [ Time Frame: at 3 months of lens wear (period 1) ]
    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
  • Bulbar Redness [ Time Frame: at 3 months of lens wear (period 1) ]
    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
  • Tarsal Roughness [ Time Frame: at 3 months of lens wear (period 1) ]
    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
conjunctival changes corneal changes superior palpebral changes [ Time Frame: Baseline, 24 hours, 1 week, 1 month, 3 months, 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Official Title  ICMJE Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Brief Summary To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Astigmatism
Intervention  ICMJE
  • Device: senofilcon A toric contact lens
    soft contact lens
  • Device: balafilcon A toric contact lens
    soft contact lens
Study Arms  ICMJE
  • Active Comparator: senofilcon A toric bilaterally
    senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
    Intervention: Device: senofilcon A toric contact lens
  • Active Comparator: balafilcon A toric bilaterally
    balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
    Intervention: Device: balafilcon A toric contact lens
  • Active Comparator: senofilcon A/balafilcon A contralaterally
    senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
    Interventions:
    • Device: senofilcon A toric contact lens
    • Device: balafilcon A toric contact 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: September 26, 2008)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to wear study lenses in parameters available
  • Non-presbyopes between the ages of 18-45
  • Understand and sign informed consent
  • Willing to follow the protocol
  • Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
  • Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
  • Adapted soft contact lens wearer
  • Swims no more than once a week
  • Has a wearable pair of spectacles.

Exclusion Criteria:

  • Any ocular or systemic disorder which may contraindicate contact lens wear
  • Any topical ocular medication
  • Aphakic
  • Corneal refractive surgery
  • Corneal distortion from hard CL wear or keratoconus
  • Pregnant or lactating
  • Grade 2 or worse slit lamp signs
  • Infectious disease
  • Previous clinical study within 2 weeks
  • Don't agree to participate
  • Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
  • Previous adverse effects that contraindicate extended lens wear.
  • Self-reported symptoms of itchiness or scratchiness with habitual lenses.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762502
Other Study ID Numbers  ICMJE CR-4498
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 May 2015

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