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

Completed · Phase 3

Conditions studied: Presbyopia

In brief

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.

Key facts

Study ID

NCT03804268

Run by

Allergan

People needed

323

Starts

2018-12-21

Expected to finish

2019-10-31

Last updated by the study team

2021-12-28

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…

• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
• Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
• 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
• Diagnosis of any type of glaucoma or ocular hypertension

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Assil Eye Institute — Beverly Hills, California, United States
• American Institute of Research — Los Angeles, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants — Sacramento, California, United States
• Haas Vision Center — Colorado Springs, Colorado, United States
• Danbury Eye Physicians and Surgeons P.C. — Danbury, Connecticut, United States
• The Eye Associates — Bradenton, Florida, United States
• Bruce Segal, MD — Delray Beach, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• USF Eye Institute — Tampa, Florida, United States
• Price Vision Group — Indianapolis, Indiana, United States
• Sabates Eye Centers — Leawood, Kansas, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Alterman, Modi & Wolter — Poughkeepsie, New York, United States
• Rochester Ophthalmological Group, PC — Rochester, New York, United States
• Mundorf Eye Center — Charlotte, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• EyeCare Professionals DWA Insight Research Clinic, LLC — Powell, Ohio, United States

Full record on ClinicalTrials.gov

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