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
- Dryness [ Time Frame: 1 Week ]