Phase 2 Completed N=75 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02516306 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: 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

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.