Evaluation of NV701 (Pilocarpine 1.25%) Compared With Vuity (Pilocarpine 1.25%) on Pupil Size in Subjects With Presbyopia

NCT06783686 | Completed Early Phase 1 FDA Drug

• 1 other identifier: NV701-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized contralateral eye study to evaluate the effect of one-time dosing of NV701 versus commercially available 1.25% pilocarpine solution on pupil size.

Conditions

Pupil Constriction

Outcome Measures

Primary Outcomes (1)

• Change in pupil size over 8 hours

  Area under the curve (AUC) of the change in mesopic pupil diameter over 8 hours after eye drop dosing

  8 hours

Secondary Outcomes (1)

• Mesopic pupil diameter difference

  8 hours

Study Arms (2)

NV701

EXPERIMENTAL

1 drop of NV701 (1.25% pilocarpine)

Vuity

ACTIVE COMPARATOR

1 drop of Vuity (1.25% pilocarpine) in contralateral eye

Drug: Pilocarpine 1.25% Eye drop

Interventions

NV701 DRUG

eye drop

Pilocarpine 1.25% Eye drop DRUG

eye drop

Vuity

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 40-55 years with presbyopia
• Able to understand and willing to sign the informed consent for the study
• Resting mesopic pupil diameter of \>4 mm in both eyes
• Change in mesopic pupil diameter of \>1 mm after 1 hour in response to pilocarpine 1.25% in both eyes
• Willing to abstain from contact lens use for 7 days before the study visit
• Women of childbearing age must have a negative urine pregnancy test at the screening visit and be willing to use a reliable method of birth control during the study

You may not qualify if:

• Anisocoria \>1 mm in photopic or mesopic conditions
• High myopia (-6.00 diopters or greater)
• Any iris abnormality making it difficult to judge pupil diameter as determined by the principal investigator
• Known allergy to any of the study products or medications
• Concurrent use of any topical prescription ophthalmic products
• History of uveitis or intraocular inflammation
• Inability to complete any of the study procedures
• History of ocular surgery other than LASIK or PRK
• History of retinal tear or retinal detachment
• Presence of retinal lattice degeneration, operculated hole, or other retinal pathology on screening exam.
• History of punctal plugs or punctal cautery in one or both eyes
• History of nasolacrimal duct surgery in one or both eyes
• History of blepharoplasty or ptosis surgery in one or both eyes
• History of glaucoma, glaucoma suspect or ocular hypertension diagnosis
• History of acute angle closure or laser peripheral iridotomy

Sponsors & Collaborators

• Novus Vision LLC: lead

Study Sites (2)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

Global Research Management, Inc

Glendale, California, 91204, United States

Location

MeSH Terms

Conditions

Miosis

Interventions

Pilocarpine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 30, 2025
• Primary Completion: April 4, 2025
• Study Completion: May 7, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)