Back to resultsA Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Primary Purpose
Presbyopia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EV06 Ophthalmic Solution
Placebo Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Vision, UNR844
Eligibility 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
Sites / Locations
- Sall Research Medical Center, Inc.
- North Valley Eye Medical Group
- Comprehensive Eye Care, Ltd.
- Total Eye Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EV06 Ophthalmic Solution
Placebo Ophthalmic Solution
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02516306
Brief Title
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 16, 2015 (Actual)
Primary Completion Date
March 10, 2016 (Actual)
Study Completion Date
March 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Vision, UNR844
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EV06 Ophthalmic Solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EV06 Ophthalmic Solution
Other Intervention Name(s)
Active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution
Other Intervention Name(s)
Inactive control (vehicle)
Primary Outcome Measure Information:
Title
Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Expert Clinical Project Lead Ophthalmology
Organizational Affiliation
Encore Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center, Inc.
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
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