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

NCT02516306 | Completed Phase 1 Results FDA Drug

• 1 other identifier: EV-C-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

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.

Conditions

Presbyopia

Keywords

Presbyopia; Vision; UNR844

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EV06 Ophthalmic Solution

EXPERIMENTAL

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

Placebo Ophthalmic Solution

PLACEBO COMPARATOR

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

Interventions

EV06 Ophthalmic Solution DRUG

Also known as: Active treatment

EV06 Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

Also known as: Inactive control (vehicle)

Placebo Ophthalmic Solution

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Encore Vision, Inc.: lead

Study Sites (4)

Sall Research Medical Center, Inc.

Artesia, California, 90701, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jerry M. Stein, Ph.D.
• Organization: Encore Vision, Inc

summercreekc@gmail.com

817-292-6963

Study Officials

• Expert Clinical Project Lead Ophthalmology

  Encore Vision, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 5, 2015
• Study Start: September 16, 2015
• Primary Completion: March 10, 2016
• Study Completion: March 10, 2016
• Last Updated: July 2, 2018
• Results First Posted: April 21, 2017

Record last verified: 2017-10

Locations

US (4)