Clinical Trial: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

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

Official Title: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Brief Summary: The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

Detailed Summary:
Sponsor: Alcon, a Novartis Company

Current Primary Outcome: Incidence of ocular discomfort device-related adverse events [ Time Frame: Day 1 at Hour 9 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Ocular Staining [ Time Frame: Day 1 at Hour 9 ]
  Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe.
• Limbal Hyperemia [ Time Frame: Day 1 at Hour 9 ]
  Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe.

Original Secondary Outcome: Same as current

Information By: Alcon Research

Dates:
Date Received: October 18, 2016
Date Started: November 2016
Date Completion:
Last Updated: December 13, 2016
Last Verified: December 2016