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Completed

NCT Number: NCT02516306

A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving 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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sall Research Medical Center, Inc., Artesia, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV06 Ophthalmic Solution

Drug

Other names: Active treatment

Placebo Ophthalmic Solution

Drug

Other names: Inactive control (vehicle)

Primary outcomes

  1. 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 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.

Sponsors and collaborators

Lead sponsor

Encore Vision, Inc.

Industry

Registry information

Official study 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 in Subjects With Presbyopia

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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