NCT02516306

A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia

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 in Subjects With Presbyopia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Encore Vision, Inc. · Industry
• Sex: All
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	EV06 Ophthalmic Solution
DRUG	Placebo Ophthalmic Solution

Timeline

• Start date: 2015-09-16
• Primary completion: 2016-03-10
• Completion: 2016-03-10
• First posted: 2015-08-05
• Last updated: 2018-07-02
• Results posted: 2017-04-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study