A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Inclusion Criteria

• •Subjective complaints of poor near vision that impact activities of daily living
• •Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications
• •Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study
• •Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
• •Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• •Participation in a blood or plasma donation program within 30 days prior to study intervention administration
• •Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit
• •Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity
• •Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy
• •History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit
• •Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy
• •Diagnosis of any type of glaucoma or ocular hypertension
• •Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled
• •Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history
• •Females who are pregnant, nursing, or planning a pregnancy during the study