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
Verified date | October 2017 |
Source | Encore Vision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Encore Vision, Inc. |
United States,
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 |
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