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

Early Phase 1

Active, not recruiting

• Conditions: Pupil Constriction
• Interventions: Drug: NV701; Drug: Pilocarpine 1.25% Eye drop

• Registration Number: NCT06783686
• Lead Sponsor: Novus Vision LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NV701	NV701	1 drop of NV701 (1.25% pilocarpine)
Vuity	Pilocarpine 1.25% Eye drop	1 drop of Vuity (1.25% pilocarpine) in contralateral eye

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mesopic pupil diameter difference	8 hours	Absolute difference in mesopic pupil diameter at 1, 2, 3, 4, 5, 6, 7, and 8 hours after administration

Trial Locations

Locations (2)

Arizona Eye Center; 🇺🇸 Chandler, Arizona, United States

Global Research Management, Inc; 🇺🇸 Glendale, California, United States