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

Completed · Phase 3

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT03857542

Run by

Allergan

People needed

427

Starts

2019-03-01

Expected to finish

2020-09-10

Last updated by the study team

2021-12-29

Who can join

Age: 40 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjective complaints of poor near vision that impact activities of daily living

You may not qualify if…

• 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

Where it is running

• Eye Center South — Dothan, Alabama, United States
• M&M Eye Institute — Prescott, Arizona, United States
• Walman Eye Center — Sun City, Arizona, United States
• Milton M. Hom, OD, FAAO — Azusa, California, United States
• Global Research Management — Glendale, California, United States
• Advanced Vision Care — Los Angeles, California, United States
• North Valley Eye Medical Group, Inc. — Mission Hills, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Corneal Consultants of Colorado — Littleton, Colorado, United States
• Benjamin Knox Lambright, MD — Crystal River, Florida, United States
• South Florida Vision Center — Fort Lauderdale, Florida, United States
• Bowden Eye Associates — Jacksonville, Florida, United States
• Mid Florida Eye Center — Mt. Dora, Florida, United States
• Newsom Eye & Laser Center — Sebring, Florida, United States
• Clayton Eye Center — Morrow, Georgia, United States
• The Midwest Center for Sight — Des Plaines, Illinois, United States
• Jacksoneye — Lake Villa, Illinois, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Heart of America Eyecare — Shawnee Mission, Kansas, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States
• Chu Laser Eye Institute — Bloomington, Minnesota, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Amel Youssef, OD — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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