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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516306
• Other study ID #: EV-C-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 16, 2015
• Est. completion date: March 10, 2016

Study information

• Verified date: October 2017
• Source: Encore Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 10, 2016
• Est. primary completion date: March 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• EV06 Ophthalmic Solution

• Placebo Ophthalmic Solution

Locations

Country	Name	City	State
United States	Sall Research Medical Center, Inc.	Artesia	California
United States	Total Eye Care	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Comprehensive Eye Care, Ltd.	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Encore Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results from the Novartis Clinical Trial Results Website