NV701 vs Pilocarpine Eye Drops for Vision Issues
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
One-time administration of NV701 or Vuity (1.25% pilocarpine) to evaluate effect on pupil size
Follow-up
Participants are monitored for changes in pupil size over 8 hours after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
1 drop of NV701 (1.25% pilocarpine)
1 drop of Vuity (1.25% pilocarpine) in contralateral eye
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novus Vision LLC
Lead Sponsor
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 Issues
Randomized 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.
4.
nei.nih.gov
nei.nih.gov/about/news-and-events/news/vision-improvement-long-lasting-treatment-blinding-blood-vessel-conditionVision 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, Patents
Its 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) / AbbVie
Short-term Efficacy and Safety of Pilocarpine Ophthalmic Solution for Presbyopia: A Systematic Review and Meta-Analysis. (PubMed, Am J Ophthalmol) ...
Safety Data Sheets
The 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 INFORMATION
THIS 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 ...
9.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_MGM99_EYE_DROPS_ADV_RELIEF_05PERCENT25PERCENT_24CS.pdfEye 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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