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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EV06 Ophthalmic Solution | Experimental | 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. |
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| Placebo Ophthalmic Solution | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV06 Ophthalmic Solution | Drug |
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| |
| Placebo Ophthalmic Solution |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Expert Clinical Project Lead Ophthalmology | Encore Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center, Inc. | Artesia | California | 90701 | United States | ||
| North Valley Eye Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | EVO6 Ophthalmic Solution | 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. |
| FG001 | Placebo | Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Day 1 - 7 |
|
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| Drug |
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| Mission Hills |
| California |
| 91345 |
| United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2: Day 8 - 91 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 7, Day 14, Day 30, Day 60, Day 90 |
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Adverse events were collected during the entire duration of the study: Day 1 through 91.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVO6 | EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes. | 0 | 50 | 0 | 50 | 18 | 50 |
| EG001 | Placebo | Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes. | 0 | 25 | 0 | 25 | 6 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Disgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry M. Stein, Ph.D. | Encore Vision, Inc | 817-292-6963 | summercreekc@gmail.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Day 14 |
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| Day 30 |
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| Day 60 |
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| Day 90 |
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