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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: EV06 Ophthalmic Solution
* Drug: Placebo Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EV06 Ophthalmic Solution<br>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<br> <br> * Other names: Active treatment;|
| Placebo Comparator: Placebo Ophthalmic Solution<br>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<br> <br> * Other names: Inactive control (vehicle);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia, Vision, UNR844