Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

(VISION-2 Trial)

Recruiting at 8 trial locations

Overseen By Greg Bennett, MSEd

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eyenovia Inc.

Must not be taking: Ophthalmic medications

Disqualifiers: Glaucoma, Ocular hypertension, Cardiac disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 visits

145 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves volunteers who will use two different eye treatments. Participants must meet specific criteria to join. The study aims to test the effectiveness and safety of these treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who need certain eye medications, except for artificial tears for dry eye syndrome.

What safety data exists for Pilocarpine Ophthalmic?

Pilocarpine, used for treating glaucoma, can cause eye-related side effects like headaches, twitching eyelids, and allergic reactions, as well as body-wide effects like nausea and sweating. Using smaller doses can reduce these side effects. ^{1 2 3 4 5}

How does pilocarpine ophthalmic differ from other drugs for eye conditions?

Pilocarpine ophthalmic in a submicron emulsion form offers a unique advantage by providing a prolonged reduction in eye pressure, lasting up to 29 hours with a single application, compared to the shorter effect of traditional pilocarpine eye drops. This could potentially allow for less frequent dosing, improving convenience for patients. ^{4 6 7 8 9}

Research Team

Tsontcho (Sean) Ianchulev, MD, MPH

Principal Investigator

Eyenovia Inc.

Eligibility Criteria

Inclusion Criteria

Poor near vision impacting daily living that requires near correction

Primary

Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants self-administer 1 of the 2 study treatments to both eyes during each of the 2 treatment visits

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for efficacy and safety assessments over a 3-hour period post-treatment

3 hours

Treatment Details

Interventions

• Pilocarpine Ophthalmic
• Placebo

Participant Groups

Group I: Pilocarpine 2% Ophthalmic Spray Experimental Treatment 1 Intervention

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Group II: Placebo Spray Placebo Group 1 Intervention

Placebo ophthalmic spray administered with the Optejet dispenser

Who Is Running the Clinical Trial?

Eyenovia Inc.

Lead Sponsor

Trials

9

Recruited

950+

References

1. United States pubmed.ncbi.nlm.nih.gov

Miotics: side effects and ways to avoid them. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Pilocarpine Hydrochloride on the Schlemm Canal in Healthy Eyes and Eyes With Open-Angle Glaucoma. [2017]

3. India pubmed.ncbi.nlm.nih.gov

Pharmacodynamic effects of pilocarpine eye drop enhanced by decreasing its volume of instillation. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Intracameral pilocarpine in topical phacoemulsification. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of two fixed beta-blocker-pilocarpine combinations. The Carteolol-Pilocarpine Study Group. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilocarpine incorporated into a submicron emulsion vehicle causes an unexpectedly prolonged ocular hypotensive effect in rabbits. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Bilateral vitreomacular traction syndrome associated with topical pilocarpine 1% ophthalmic solution. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Dose-response of topical pilocarpine in the normotensive and glaucomatous Beagle. [2013]

9. England pubmed.ncbi.nlm.nih.gov

In Vitro and In-Eye Comparison of Commercial Pilocarpine Ophthalmic Solution and an Optimized, Reformulated Pilocarpine for Presbyopia Treatment. [2023]