Presbyopia
Conditions
Keywords
Presbyopia, Vision, UNR844
Brief 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.
Detailed 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.
Interventions
DRUGEV06 Ophthalmic Solution
DRUGPlacebo Ophthalmic Solution
Sponsors
Encore Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Baseline, Day 7, Day 14, Day 30, Day 60, Day 90 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EV06 Ophthalmic Solution EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days. | 50 |
| Placebo Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days. | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2: Day 8 - 91 | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | EV06 Ophthalmic Solution | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 3.2 | 51.4 years STANDARD_DEVIATION 3 | 50.5 years STANDARD_DEVIATION 3.1 |
| Region of Enrollment United States | 50 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 33 Participants | 20 Participants | 53 Participants |
| Sex: Female, Male Male | 17 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 25 |
| other Total, other adverse events | 18 / 50 | 6 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
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.
Time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
Population: Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 1 | 3.2 units on a scale | Standard Deviation 2.4 |
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 7 | 2.4 units on a scale | Standard Deviation 2.4 |
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 14 | 2.2 units on a scale | Standard Deviation 2.2 |
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 30 | 2.4 units on a scale | Standard Deviation 2 |
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 60 | 2.1 units on a scale | Standard Deviation 2.1 |
| EVO6 Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 90 | 2.1 units on a scale | Standard Deviation 2.4 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 60 | 3.0 units on a scale | Standard Deviation 2.5 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 1 | 3.3 units on a scale | Standard Deviation 2.5 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 30 | 2.2 units on a scale | Standard Deviation 2.2 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 7 | 2.2 units on a scale | Standard Deviation 2.2 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 90 | 2.1 units on a scale | Standard Deviation 2.2 |
| Placebo Ophthalmic Solution | Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit | Day 14 | 2.3 units on a scale | Standard Deviation 2.2 |