Clinical Trial: Clinical Evaluation of the Safety and Efficacy of FID 120947A

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

Official Title:

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity. This study will be conducted in Japan.

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome:

• Percentage of Eyes With Visibly Clean Lenses at each visit [ Time Frame: Up to Day 180 ]
  Worn study lenses will be removed and evaluated for deposits. Deposits found on the lenses will be defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered.
• Percentage of Eyes With Crystalline Deposits by Type at each visit [ Time Frame: Up to Day 180 ]
  Worn study lenses will be removed and evaluated for deposits. Deposits found on the lenses will be defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered.
• Percentage of Eyes With Film Deposits by Type at each visit [ Time Frame: Up to Day 180 ]
  Worn study lenses will be removed and evaluated for deposits. Deposits found on the lenses will be defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered.
• Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at each visit [ Time Frame: Up to Day 180 ]
  Distance visual acuity (VA) will be measured using Snellen charts.
• Average Lens Wear Time (averaged over the last 3 days) at each visit [ Time Frame: Up to Day 180 ]
  Subject will record a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?"
• Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Alcon Research
  

  Dates:
  Date Received: May 11, 2016
  Date Started: May 20, 2016
  Date Completion:
  Last Updated: January 26, 2017
  Last Verified: January 2017