Phase 2
N=75
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT02516306 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit — 3.2; 3.3; 2.4; 2.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EV06 Ophthalmic Solution (Drug); Placebo Ophthalmic Solution (Drug)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- Encore Vision, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit |
3.2; 3.3; 2.4; 2.2; 2.2; 2.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02516306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.