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

Encore Vision, Inc.75 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Presbyopia

Interventions

EV06 Ophthalmic SolutionDRUG

Placebo Ophthalmic SolutionDRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (4)

Sall Research Medical Center, Inc.

Artesia, California, United States

North Valley Eye Medical Group

Mission Hills, California, United States

Comprehensive Eye Care, Ltd.

Washington, Missouri, United States

Total Eye Care

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90

Data from ClinicalTrials.gov

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