Nyxol Eye Drops + Low-Dose Pilocarpine Eye Drops for Presbyopia
(VEGA-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests eye drops to determine if they can help people with presbyopia, which is difficulty seeing things up close, such as when reading. Researchers are evaluating how well Nyxol, a phentolamine eye drop, works alone and with a low dose of pilocarpine (another type of eye drop) to improve near vision. The trial includes different groups that will test Nyxol, pilocarpine, and placebos (inactive treatments) in various combinations. People who have difficulty seeing up close and rely on reading glasses or bifocals might be suitable for this study. 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?
You will need to stop using any topical eye medications, except for certain over-the-counter products, at least 7 days before the trial and during the study. If you are taking any systemic adrenergic or cholinergic drugs, you should not change your dosage or start new ones within 7 days before the trial or during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies found Nyxol eye drops to be safe, with most users experiencing no issues. No new safety concerns emerged. Research also shows that combining Nyxol with a small amount of pilocarpine is generally safe. However, caution is advised for some individuals when driving at night after using pilocarpine. Although these treatments are in the final testing stages and are typically considered safe based on previous tests, awareness of potential risks remains important.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about Nyxol Eye Drops combined with low-dose pilocarpine for presbyopia because they offer a new way to improve near vision. Most treatments for presbyopia, like reading glasses or multifocal contacts, don't address the eye's underlying ability to focus. Nyxol works by using phentolamine ophthalmic solution 0.75%, which may help the eye's muscles to focus better. This combination also includes low-dose pilocarpine, known for its ability to constrict the pupil and enhance depth of focus. Together, they could provide a non-invasive alternative to glasses or contact lenses, potentially offering more natural vision improvement for those with presbyopia.
What evidence suggests that this trial's treatments could be effective for presbyopia?
Research has shown that Nyxol, an eye drop containing Phentolamine Ophthalmic Solution 0.75%, helps people with presbyopia improve near vision. One study found that 27.2% of participants using Nyxol improved by at least 15 letters on a near vision test, demonstrating its effectiveness. In this trial, some participants will receive Nyxol alone, while others will receive a combination of Nyxol with a small amount of another eye drop, pilocarpine, to assess if this combination enhances results. This mix aims to help people see clearly up close while wearing glasses for distance vision. While Nyxol alone has shown good results, the combination might offer even more benefits for those with presbyopia.25678
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nyxol alone or with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low dose pilocarpine
- Low dose pilocarpine vehicle
- Phentolamine Ophthalmic Solution 0.75%
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ocuphire Pharma, Inc.
Lead Sponsor