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

Encore Vision

Status and phase: Completed; Phase 2; Phase 1

Conditions: Presbyopia

Treatments: Drug: Placebo Ophthalmic Solution; Drug: EV06 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516306

EV-C-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

75 participants in 2 patient groups, including a placebo group

EV06 Ophthalmic Solution

Experimental group

Description:

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.

Treatment:

Drug: EV06 Ophthalmic Solution

Placebo Ophthalmic Solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Ophthalmic Solution