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

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