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

• ClinicalTrials.gov Identifier: NCT02516306
• Recruitment Status: Completed
• First Posted: August 5, 2015
• Results First Posted: April 21, 2017
• Last Update Posted: July 2, 2018
• Sponsor: Encore Vision, Inc.
• Information provided by (Responsible Party): Encore Vision, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Presbyopia	Drug: EV06 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 in Subjects With Presbyopia
• Actual Study Start Date: September 16, 2015
• Actual Primary Completion Date: March 10, 2016
• Actual Study Completion Date: March 10, 2016

Arms and Interventions

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 Name: 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 Name: Inactive control (vehicle)

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Sall Research Medical Center, Inc.

Artesia, California, United States, 90701

North Valley Eye Medical Group

Mission Hills, California, United States, 91345

United States, Missouri

Comprehensive Eye Care, Ltd.

Washington, Missouri, United States, 63090

United States, Tennessee

Total Eye Care

Memphis, Tennessee, United States, 38119

Sponsors and Collaborators

Encore Vision, Inc.

Investigators

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

More Information

• Responsible Party: Encore Vision, Inc.
• ClinicalTrials.gov Identifier: NCT02516306
• Other Study ID Numbers: EV-C-002
• First Posted: August 5, 2015
• Results First Posted: April 21, 2017
• Last Update Posted: July 2, 2018
• Last Verified: October 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Encore Vision, Inc.:

Presbyopia; Vision; UNR844

Additional relevant MeSH terms:

Presbyopia; Refractive Errors; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions