Clinical Trial: A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1/2 Prospective, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution, in Improving Distance Corrected Near Vision i
Brief Summary: The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and effective in improving distance corrected near vision in people who have presbyopia.
Detailed Summary: Study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.
Sponsor: Encore Vision, Inc.
Current Primary Outcome: Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit [ Time Frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90 ]
Original Primary Outcome: Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 90 days ]
Current Secondary Outcome:
Original Secondary Outcome: Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 90 days ]
Information By: Encore Vision, Inc.
Dates:
Date Received: July 23, 2015
Date Started: September 16, 2015
Date Completion:
Last Updated: March 10, 2017
Last Verified: March 2017