A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - 55 |
| Updated: | 7/4/2018 |
| Start Date: | September 16, 2015 |
| End Date: | March 10, 2016 |
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
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.
effective in improving distance corrected near vision in people who have presbyopia.
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.
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.
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
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