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

Novus Vision LLC

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Pupil Constriction

Treatments: Drug: NV701; Drug: Pilocarpine 1.25% Eye drop

Study type: Interventional

Funder types: Industry

Identifiers

NCT06783686

NV701-02

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

NV701

Experimental group

Description:

1 drop of NV701 (1.25% pilocarpine)

Treatment:

Drug: NV701

Vuity

Active Comparator group

Description:

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

Treatment:

Drug: Pilocarpine 1.25% Eye drop