Pilocarpine Ophthalmic Spray for Presbyopia
(VISION-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an eye spray called pilocarpine to determine its effectiveness for people with presbyopia, a common condition where near vision becomes blurry with age. Participants will apply either the pilocarpine spray or a placebo (a fake treatment) to their eyes and then undergo vision and eye health assessments over a few hours. The trial aims to determine if the spray safely improves close-up vision. Ideal candidates are those who struggle with near vision tasks like reading or using a phone, but not those with serious eye conditions or a history of eye surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for presbyopia.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that pilocarpine eye treatments are usually well-tolerated. Studies by the International Agency for Research on Cancer have found that pilocarpine does not cause cancer. However, some possible side effects exist. For instance, if the eye medicine becomes contaminated, it could cause serious eye damage or even vision loss.
To prevent this, keep the container tightly closed. While pilocarpine is considered "toxic" if swallowed in large amounts, this study uses a spray for the eyes, which differs. Remember, any medicine can have side effects, so it's important to be informed and follow instructions carefully.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for presbyopia, which often involve reading glasses or contact lenses, pilocarpine ophthalmic spray is unique because it offers a non-invasive way to temporarily improve near vision. This spray uses a 2% pilocarpine solution delivered through the innovative Optejet dispenser, which allows for precise application directly to the eyes. Researchers are excited about this treatment because it could offer a quick and convenient alternative for those who want to avoid traditional corrective lenses.
What evidence suggests that Pilocarpine Ophthalmic might be an effective treatment for eye conditions?
Research has shown that pilocarpine in an eye spray can assist people with presbyopia, a condition where close-up vision becomes difficult with age. In earlier studies, a 1.25% pilocarpine spray improved near vision for up to 30 days. Many participants could read two to three lines better on vision charts just three hours after application. This indicates that pilocarpine can enhance vision in the short term and may be beneficial for longer durations. In this trial, participants will receive a slightly stronger 2% pilocarpine ophthalmic spray, which could yield even better results.678910
Who Is on the Research Team?
Tsontcho (Sean) Ianchulev, MD, MPH
Principal Investigator
Eyenovia Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer 1 of the 2 study treatments to both eyes during each of the 2 treatment visits
Follow-up
Participants are monitored for efficacy and safety assessments over a 3-hour period post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pilocarpine Ophthalmic
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eyenovia Inc.
Lead Sponsor