A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia (GEMINI 2)

Allergan

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Other: Vehicle; Drug: Pilocarpine HCl Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03857542

1883-302-013

Details and patient eligibility

About

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.

Enrollment: 427 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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427 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Participants received one drop of vehicle in each eye, once daily, for up to 30 days.

Treatment:

Other: Vehicle

Pilocarpine HCl Ophthalmic Solution

Experimental group

Description:

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Treatment:

Drug: Pilocarpine HCl Ophthalmic Solution