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Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments 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 2% Ophthalmic Spray | Experimental | 2% pilocarpine ophthalmic spray administered with the Optejet dispenser |
|
| Placebo Spray | Placebo Comparator | Placebo ophthalmic spray administered with the Optejet dispenser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine Ophthalmic administered with the Optejet dispenser | Combination Product | Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA) | The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA 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-2 Study Site #57 | San Diego | California | 92131 | United States | ||
| VISION-2 Study Site #59 |
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|
| Placebo administered with the Optejet dispenser | Combination Product | Vehicle ophthalmic solution administered with the Optejet dispenser |
|
| Fairfield |
| Connecticut |
| 06890 |
| United States |
| VISION-2 Study Site #56 | Louisville | Kentucky | 40206 | United States |
| VISION-2 Study Site #19 | Columbus | Ohio | 43210 | United States |
| VISION-2 Study Site #58 | Philadelphia | Pennsylvania | 19141 | United States |
| VISION-2 Study Site #62 | Sioux Falls | South Dakota | 57018 | United States |
| VISION-2 Study Site #55 | Memphis | Tennessee | 38119 | United States |
| VISON-2 Study Site #60 | Austin | Texas | 78731 | United States |
| VISION-2 Study Site #61 | Draper | Utah | 84020 | United States |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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