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

NCT ID: NCT06783686

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-05-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

NV701

1 drop of NV701 (1.25% pilocarpine)

Group Type: EXPERIMENTAL

No interventions assigned to this group

Vuity

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

Group Type: ACTIVE_COMPARATOR

Pilocarpine 1.25% Eye drop

Intervention Type: DRUG

eye drop

Interventions

NV701

eye drop

Intervention Type: DRUG

Pilocarpine 1.25% Eye drop

eye drop

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novus Vision LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Eye Center

Chandler, Arizona, United States

Global Research Management, Inc

Glendale, California, United States

Countries

United States

Other Identifiers

NV701-02

Identifier Type: -

Identifier Source: org_study_id