A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Pilocarpine HCl Ophthalmic Solution; Vehicle
Intervention description: Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.; Vehicle, one drop in each eye, once daily, for up to 30 days.
Intervention MeSH terms: Ophthalmic Solutions; Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution
      (AGN-190584) in an expanded participant population to establish efficacy, safety, and
      tolerability versus the vehicle-control when administered, over a 30-day study intervention
      period, once daily bilaterally in participants with presbyopia.
    

Eligibility criteria:

        Inclusion Criteria

        Subjective complaints of poor near vision that impact activities of daily living

        Exclusion Criteria

        Uncontrolled systemic disease

        Any clinical condition or previous surgery that might affect the absorption, distribution,
        biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic
        intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular
        surgery. However, participants with history of photorefractive keratectomy (PRK) or
        laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA)
        meeting inclusion criteria will be allowed to enroll.

        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