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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Encore Vision, Inc.
ClinicalTrials.gov Identifier:
NCT02516306
First received: July 23, 2015
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Presbyopia Drug: EV06 Ophthalmic Solution Drug: Placebo Ophthalmic Solution Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Encore Vision, Inc.:

Primary Outcome Measures:
  • 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 Comfortable) 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.


Enrollment: 75
Actual Study Start Date: September 16, 2015
Study Completion Date: April 2016
Primary Completion Date: March 10, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02516306

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     History of Changes
Other Study ID Numbers: EV-C-002
Study First Received: July 23, 2015
Results First Received: March 10, 2017
Last Updated: March 10, 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

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions

ClinicalTrials.gov processed this record on September 21, 2017