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

Effect on Pupil Size After One-time Administration of NV701 (Pilocarpine 1.25%) vs. Vuity (Pilocarpine 1.25%)

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

Study Overview

• Status: Completed
• Conditions: Pupil Constriction
• Intervention / Treatment: Drug: NV701; Drug: Pilocarpine 1.25% Eye drop

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
  • California
    • Glendale, California, United States, 91204
      • Global Research Management, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• History of moderate or severe dry eye disease
• Females who are pregnant, nursing, or planning a pregnancy during the study
• Females of childbearing potential and males with partners of childbearing potential who do not agree to use reliable contraception during the study
• Uncontrolled systemic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NV701; 1 drop of NV701 (1.25% pilocarpine)	Drug: NV701; eye drop
Active Comparator: Vuity; 1 drop of Vuity (1.25% pilocarpine) in contralateral eye	Drug: Pilocarpine 1.25% Eye drop; eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesopic pupil diameter difference	Absolute difference in mesopic pupil diameter at 1, 2, 3, 4, 5, 6, 7, and 8 hours after administration	8 hours

Collaborators and Investigators

• Sponsor: Novus Vision LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Pupil Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Miosis; Pharmaceutical Solutions; Heterocyclic Compounds; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Alkaloids; Solutions; Specialty Uses of Chemicals; Ophthalmic Solutions; Pilocarpine
• Other Study ID Numbers: NV701-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No