Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults (VISION-1)
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ClinicalTrials.gov Identifier: NCT04657172 |
Recruitment Status :
Completed
First Posted : December 8, 2020
Last Update Posted : August 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Presbyopia | Drug: Pilocarpine Ophthalmic Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia |
Actual Study Start Date : | December 15, 2020 |
Actual Primary Completion Date : | March 26, 2021 |
Actual Study Completion Date : | March 26, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Pilocarpine 1% Solution
1% pilocarpine ophthalmic solution administered with the Optejet dispenser
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Drug: Pilocarpine Ophthalmic
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
Other Name: MicroLine |
Experimental: Pilocarpine 2% Solution
2% pilocarpine ophthalmic solution administered with the Optejet dispenser
|
Drug: Pilocarpine Ophthalmic
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
Other Name: MicroLine |
Placebo Comparator: Placebo Solution
Placebo ophthalmic solution administered with the Optejet dispenser
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Drug: Placebo
Vehicle ophthalmic solution administered with the Optejet microdose dispenser |
- Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) [ Time Frame: 120 minutes post-dosing ]The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.

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Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Primary Inclusion Criteria:
- Poor near vision impacting daily living that requires near correction
- Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
- Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
- Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive
Primary Exclusion Criteria:
- Diagnosis of glaucoma or ocular hypertension
- Narrow iridocorneal angles
- History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
- Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
- Presence/history of a severe/serious ocular condition or any other unstable medical condition
- Presence or history of manifest strabismus, amblyopia, or nystagmus
- Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
- Clinically significant external ocular inflammation within 30 days of Screening Visit
- Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
- Known pilocarpine allergy or contraindication to use of pilocarpine
- Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
- Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657172
United States, California | |
VISION-1 Study Site #21 | |
Azusa, California, United States, 91702 | |
VISION-1 Study Site #52 | |
Newport Beach, California, United States, 92663 | |
United States, Colorado | |
VISION-1 Study Site #54 | |
Fort Collins, Colorado, United States, 80528 | |
United States, Florida | |
VISION-1 Study Site #53 | |
Orlando, Florida, United States, 32803 | |
United States, New York | |
VISION-1 Study Site #50 | |
New York, New York, United States, 10036 | |
United States, North Carolina | |
VISION-1 Study Site #17 | |
High Point, North Carolina, United States, 27262 | |
VISION-1 Study Site #22 | |
Raleigh, North Carolina, United States, 27603 | |
United States, Pennsylvania | |
VISION-1 Study Site #51 | |
Cranberry Township, Pennsylvania, United States, 16066 | |
United States, Texas | |
VISION-1 Study Site #03 | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Tsontcho (Sean) Ianchulev, MD, MPH | Eyenovia Inc. |
Responsible Party: | Eyenovia Inc. |
ClinicalTrials.gov Identifier: | NCT04657172 |
Other Study ID Numbers: |
EYN-PRS-PI-31 |
First Posted: | December 8, 2020 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Presbyopia Refractive Errors Eye Diseases Pilocarpine Miotics Autonomic Agents Peripheral Nervous System Agents |
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