A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily

Completed · Phase 3 · Has a placebo group

Conditions studied: Presbyopia

In brief

Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States. Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days. There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT04983589

Run by

Allergan

People needed

230

Starts

2021-09-02

Expected to finish

2022-02-11

Last updated by the study team

2023-03-21

Who can join

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

You may qualify if…

• Objective and subjective evidence of presbyopia.

You may not qualify if…

• 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.
• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

Where it is running

• Empire Eye and Laser /ID# 231433 — Bakersfield, California, United States
• Global Research Management /ID# 231300 — Glendale, California, United States
• United Medical Research Institute /ID# 233982 — Inglewood, California, United States
• North Valley Eye Medical Group, Inc. /ID# 231270 — Mission Hills, California, United States
• The Eye Research Foundation /ID# 231274 — Newport Beach, California, United States
• Martel Eye Medical Group /ID# 231332 — Rancho Cordova, California, United States
• Nature Coast Clinical Research - Crystal River /ID# 231298 — Crystal River, Florida, United States
• Bruce Segal, MD /ID# 231413 — Delray Beach, Florida, United States
• Clayton Eye Clinical Research, LLC /ID# 231243 — Morrow, Georgia, United States
• Jacksoneye, SC /ID# 231374 — Lake Villa, Illinois, United States
• Price Vision Group /ID# 231261 — Indianapolis, Indiana, United States
• Kannarr Eye Care /ID# 231363 — Pittsburg, Kansas, United States
• Cincinnati Eye Institute- Edgewood /ID# 231356 — Edgewood, Kentucky, United States
• The Eye Care Institute /ID# 231275 — Louisville, Kentucky, United States
• Rochester Ophthalmological Group PC /ID# 231371 — Rochester, New York, United States
• Southern College of Optometry /ID# 231325 — Memphis, Tennessee, United States
• Total Eye Care, PA /ID# 231245 — Memphis, Tennessee, United States
• Advancing Vision Research /ID# 231244 — Smyrna, Tennessee, United States
• Hill Country Eye Center /ID# 231293 — Cedar Park, Texas, United States
• The Cataract & Glaucoma Center /ID# 231292 — El Paso, Texas, United States
• Eye associates /ID# 231262 — San Antonio, Texas, United States
• Hoopes, Durrie, Rivera Research /ID# 231273 — Draper, Utah, United States
• Country Hills Eye Center /ID# 231414 — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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