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
Overview
- Phase
- Phase 1
- Intervention
- EV06 Ophthalmic Solution
- Conditions
- Presbyopia
- Sponsor
- Encore Vision, Inc.
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: EV06 Ophthalmic Solution
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.
Intervention: Placebo Ophthalmic Solution
Outcomes
Primary Outcomes
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.