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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: EV06 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center, Inc.
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 45 to 55 years of age
• Distance Corrected Near Visual Acuity worse than 20/40
• Best Corrected Distance Visual Acuity of 20/20 or better in each eye
• Willing and able to sign consent, following study instructions

Exclusion Criteria:

• Certain pupillary conditions
• Significant astigmatism, glaucoma, diabetes, cataracts, eye surgery, ocular trauma or accommodative issues
• contact lens wear within 3 days prior to and for duration of study
• use of prohibited medications
• participation in a clinical study within 30 days prior

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EV06 Ophthalmic Solution; EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.	Drug: EV06 Ophthalmic Solution; Other Names: Active treatment
Placebo Comparator: Placebo Ophthalmic Solution; Placebo Ophthalmic Solution (EV06 vehicle): Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.	Drug: Placebo Ophthalmic Solution; Other Names: Inactive control (vehicle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit	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 Uncomfortable) 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.	Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

Collaborators and Investigators

• Sponsor: Encore Vision, Inc.
• Investigators: Study Director: Expert Clinical Project Lead Ophthalmology, Encore Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2015
• Primary Completion (Actual): March 10, 2016
• Study Completion (Actual): March 10, 2016

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Vision; Presbyopia; UNR844
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: EV-C-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No