NV701 vs Pilocarpine Eye Drops for Vision Issues

No longer recruiting at 1 trial location
SD
Overseen ByStudy Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a one-time dose of NV701 eye drops with a common eye drop, pilocarpine, in altering pupil size. It seeks to determine which option might better address vision issues related to presbyopia (difficulty focusing on close objects). The study tests each treatment in one eye to allow direct comparison of effects. Individuals with presbyopia, aged 40 to 55, who notice changes in pupil size after using pilocarpine, might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how NV701 works in people, offering participants a chance to explore new treatment options for presbyopia.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use any topical prescription eye medications while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pilocarpine, the main ingredient in NV701, is usually well-tolerated in eye drops. The FDA has already approved pilocarpine for other uses, indicating its general safety. Studies have found pilocarpine effective and safe for treating eye conditions. Most people do not report serious side effects, though some may experience minor irritation. Overall, the safety data suggests that NV701 is likely safe for short-term use in the eyes.12345

Why do researchers think this study treatment might be promising?

NV701 is unique because it offers a new approach to managing vision issues by utilizing the same active ingredient, pilocarpine, as existing treatments like Vuity, but with a potentially different formulation that might enhance its effectiveness or side effect profile. Researchers are excited because NV701 could improve upon the standard of care by providing better vision enhancement or reducing side effects commonly associated with current pilocarpine-based eye drops. This has the potential to make a significant difference for patients seeking more effective or comfortable treatment options for their vision problems.

What evidence suggests that this trial's treatments could be effective for vision issues?

This trial will compare NV701 with Vuity, both containing pilocarpine, for vision issues. Research has shown that pilocarpine, the main ingredient in NV701, can reduce pupil size, potentially improving vision clarity in certain conditions. Past patients have found pilocarpine helpful for vision problems like presbyopia, where close-up vision becomes blurry with age. Studies indicate that pilocarpine works by reducing pupil size, aiding light focus on the back of the eye. While NV701 is still under trial, it functions similarly to other pilocarpine eye drops already available, suggesting NV701 could effectively improve vision.16789

Are You a Good Fit for This Trial?

This trial is for individuals with presbyopia, a condition where the eyes lose the ability to focus on close objects, leading to constricted pupils. Participants should not have any other significant eye conditions that could interfere with the study.

Inclusion Criteria

My pupils change size significantly after using pilocarpine eye drops.
Able to understand and willing to sign the informed consent for the study
Resting mesopic pupil diameter of >4 mm in both eyes
See 3 more

Exclusion Criteria

I have had eyelid or droopy eyelid surgery.
Known allergy to any of the study products or medications
I have had acute angle closure or a laser procedure on my eye.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

One-time administration of NV701 or Vuity (1.25% pilocarpine) to evaluate effect on pupil size

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in pupil size over 8 hours after treatment

8 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • NV701
Trial Overview The study is testing NV701 against Vuity (both are pilocarpine 1.25% eye drops) to see which one better controls pupil size in people with presbyopia. Each participant's eyes will receive different treatments for comparison.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: NV701Experimental Treatment1 Intervention
Group II: VuityActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novus Vision LLC

Lead Sponsor

Trials
1
Recruited
50+

Citations

NCT06783686 | Evaluation of NV701 (Pilocarpine 1.25% ...Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...
NV701 vs Pilocarpine Eye Drops for Vision IssuesRandomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.
Visual Outcomes in Patients Contralaterally Implanted With ...Preexisting macular disease or other retinal degenerative disease expected to cause vision loss. Glaucoma. Severe dry eye disease. Nystagmus or strabismus.
Vision improvement is long-lasting with treatment for blinding ...NIH-funded study finds many patients with retinal vein occlusion have vision benefits, but require long-term monitoring and treatment.
Miosis - Drugs, Targets, PatentsIts lead asset, BRIMOCHOL™ PF, is a novel, pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia, a condition that ...
Vuity (pilocarpine) / AbbVieShort-term Efficacy and Safety of Pilocarpine Ophthalmic Solution for Presbyopia: A Systematic Review and Meta-Analysis. (PubMed, Am J Ophthalmol) ...
Safety Data SheetsThe Safety Data Sheets (SDS) are intended to provide health, safety and environmental information for the people handling these products in the workplace.
MATERIAL SAFETY DATA INFORMATIONTHIS PRODUCT IS NON-HAZARDOUS AND IS APPROVED BY THE FDA. IT IS AN. AQUEOUS SOLUTION AND IS NOT CONSIDERED TO CONSTITUTE A HAZARD. OSHA. A ...
Eye Drops Advanced Relief SAFETY DATA SHEET (SDS)EYE: Non-irritating to the eyes when used as directed. SKIN: Non-irritating to skin or mucous membranes when used as ...
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