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 ]

Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled "0" (Very Comfortable), "5" (Comfortable) and "10 (Very Comfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested.


Original Primary Outcome: Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 90 days ]

Is there a change in the DCNVA score?


Current Secondary Outcome:

Original Secondary Outcome: Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 90 days ]

Is there a change in the BCDVA score?


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