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Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine 1% Solution | Experimental | 1% pilocarpine ophthalmic solution administered with the Optejet dispenser |
|
| Pilocarpine 2% Solution | Experimental | 2% pilocarpine ophthalmic solution administered with the Optejet dispenser |
|
| Placebo Solution | Placebo Comparator | Placebo ophthalmic solution administered with the Optejet dispenser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine Ophthalmic | Drug | Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) | The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline. | 120 minutes post-dosing |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho (Sean) Ianchulev, MD, MPH | Eyenovia Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VISION-1 Study Site #21 | Azusa | California | 91702 | United States | ||
| VISION-1 Study Site #52 |
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|
| Placebo | Drug | Vehicle ophthalmic solution administered with the Optejet microdose dispenser |
|
| Newport Beach |
| California |
| 92663 |
| United States |
| VISION-1 Study Site #54 | Fort Collins | Colorado | 80528 | United States |
| VISION-1 Study Site #53 | Orlando | Florida | 32803 | United States |
| VISION-1 Study Site #50 | New York | New York | 10036 | United States |
| VISION-1 Study Site #17 | High Point | North Carolina | 27262 | United States |
| VISION-1 Study Site #22 | Raleigh | North Carolina | 27603 | United States |
| VISION-1 Study Site #51 | Cranberry Township | Pennsylvania | 16066 | United States |
| VISION-1 Study Site #03 | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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