Clinical Trial: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

Brief Summary: Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Detailed Summary: CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.
Sponsor: Coopervision, Inc.

Current Primary Outcome:

  • Comfort [ Time Frame: Baseline and 1 Week ]
    Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
  • Handling [ Time Frame: Baseline and 1 Week ]
    Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
  • Vision [ Time Frame: Baseline and 1 Week ]
    Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
  • High Visual Acuity [ Time Frame: Baseline and 1 Week ]
    High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
  • Low Visual Acuity [ Time Frame: Baseline and 1 Week ]
    Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
  • Lens Surface - Wettability [ Time Frame: Baseline and 1 Week ]
    Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wetta

    Original Primary Outcome: Subjective ratings for comfort [ Time Frame: 1 Week ]

    Subjective ratings of lens performance for comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)


    Current Secondary Outcome:

    • Dryness [ Time Frame: 1 Week ]
      Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.
    • Overall Satisfaction [ Time Frame: Baseline and 1 week ]
      Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.


    Original Secondary Outcome:

    Information By: Coopervision, Inc.

    Dates:
    Date Received: March 31, 2015
    Date Started: April 2015
    Date Completion:
    Last Updated: January 18, 2017
    Last Verified: January 2017