Inclusion Criteria

• ≥40 and ≤64 years of age
• BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions
• DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not >0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
• For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better
• Photopic PD of ≥3 mm in either eye

Exclusion Criteria

Ophthalmic:^*

• Use of any topical prescription or over-the-counter (OTC) ophthalmic medications within 7 days of screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in the criterion below
• Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
• Current use of any topical ophthalmic therapy for dry eye
• Tear break-up time of <5 seconds or corneal fluorescein staining (CFS) Grade ≥2 in the inferior zone or ≥1 in the central zone using the National Eye Institute scale
• Clinically significant ocular disease that might interfere with the study as deemed by the Investigator
• Recent or current evidence of ocular infection or inflammation
• Any history of herpes simplex or herpes zoster keratitis
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations
• Prior participation in a study involving the use of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Ocular trauma within 6 months prior to screening
• Ocular surgery or any ocular laser treatment within 6 months prior to screening
• Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs)
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris
• Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 min following dosing

Exclusion Criteria

Systemic:

• Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists or any systemic cholinergic parasympathomimetic agent
• Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator
• Initiation of treatment with, or any changes to, the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening or during the study
• Participation in any investigational study within 30 days prior to screening
• Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
• Resting HR outside the range of ≤50 to ≥110 bpm
• Hypertension with resting DBP >105 mmHg or SBP >160 mmHg

Primary Endpoint

• Percentage of subjects with ≥15 letters of improvement in photopic binocular DCNVA and with <5 letters of loss in photopic binocular BCDVA in phentolamine ophthalmic solution 0.75%-treated subjects

Secondary Endpoints

• Percentage of subjects with ≥15 letters of improvement in photopic binocular DCNVA and with <5 letters of loss in photopic binocular BCDVA in LDP+phentolamine ophthalmic solution 0.75%-treated subjects
• Percentage of subjects with ≥15 letters of improvement in photopic binocular DCNVA and with <5 letters of loss in binocular photopic BCDVA from baseline (excluding primary and key secondary outcome timepoints)
• Percentage of subjects with ≥5, ≥10, and ≥15 letters of improvement in photopic DCNVA from baseline (monocular and binocular)
• Change in photopic DCNVA from baseline (monocular and binocular)
• Percentage of subjects with loss or improvement in photopic and mesopic BCDVA from baseline (monocular and binocular)
• Change in photopic and mesopic BCDVA from baseline (monocular and binocular)
• Percentage of subjects with ≥5, ≥10, and ≥15 letters of improvement in mesopic binocular DCNVA from baseline
• Change in mesopic binocular DCNVA from baseline
• Change and Percentage change in photopic PD from baseline

Secondary Endpoints (continued)

• Percentage of subjects with photopic PD of <3.5, <3.0, <2.5, <2.0, and <1.5 mm
• Percentage of subjects with photopic PD of 1.5 to <2.0 mm, 2.0 to <2.5 mm, 2.5 to <3.0 mm, and 3.0 to <3.5 mm
• Change and percentage change in mesopic PD from baseline
• Percentage of subjects with mesopic PD of <3.5, <3.0, <2.5, <2.0, and <1.5 mm
• Percentage of subjects with mesopic PD of 1.5 to <2.0 mm, 2.0 to <2.5 mm, 2.5 to <3.0 mm, and 3.0 to <3.5 mm
• Percentage of subjects with baseline photopic DCNVA ≤20/63, ≤20/80, ≤20/100, ≤20/125, and ≤20/160, with a ≥10-letter and ≥15-letter improvement in photopic DCNVA
• Percentage of subjects with baseline photopic DCNVA from 20/50 to 20/63, 20/50 to 20/80, 20/50 to 20/100, 20/50 to 20/125, and 20/50 to 20/160, with a ≥10-letter and ≥15-letter improvement in photopic DCNVA
• Subject questionnaire responses related to change in near vision and satisfaction with near vision

This clinical trial does not currently have results