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

NCT03804268 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 1883-301-013
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 36

Brief Summary

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3

  Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.

  Baseline (Day 1) to Day 30 (Hour 3)

Secondary Outcomes (12)

• Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6

  Baseline (Day 1) to Day 30 (Hour 6)

• Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8

  Baseline (Day 1) to Day 30 (Hour 8)

• Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5

  Baseline (Day 1) to Day 30 (Hour 0.5)

• Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1

  Day 30 (Hour 1)

• Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3

  Baseline (Day 1) to Day 30 (Hour 3)

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

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

Other: Vehicle

Pilocarpine HCl Ophthalmic Solution

EXPERIMENTAL

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

Drug: Pilocarpine HCl Ophthalmic Solution

Interventions

Vehicle OTHER

Vehicle, one drop in each eye, once daily, for up to 30 days.

Vehicle

Pilocarpine HCl Ophthalmic Solution DRUG

Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.

Also known as: AGN-190584, VUITY

Pilocarpine HCl Ophthalmic Solution

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (36)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants

Sacramento, California, 95815, United States

Location

Haas Vision Center

Colorado Springs, Colorado, 80919, United States

Location

Danbury Eye Physicians and Surgeons P.C.

Danbury, Connecticut, 06810, United States

Location

The Eye Associates

Bradenton, Florida, 34209, United States

Location

Bruce Segal, MD

Delray Beach, Florida, 33484, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

USF Eye Institute

Tampa, Florida, 33612, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Sabates Eye Centers

Leawood, Kansas, 66211, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Mundorf Eye Center

Charlotte, North Carolina, 28204, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

EyeCare Professionals DWA Insight Research Clinic, LLC

Powell, Ohio, 43065, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Nashville Vision Associates

Nashville, Tennessee, 37205, United States

Location

Hill Country Eye Center

Cedar Park, Texas, 78613, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

PNV Clinical Research LLC

San Antonio, Texas, 78229, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Hoopes, Durrie, Rivera Research

Draper, Utah, 84020, United States

Location

Related Publications (3)

• Lievens CW, Hom MM, McLaurin EB, Yuan J, Safyan E, Liu H. Pilocarpine HCl 1.25% for treatment of presbyopia after laser vision correction: pooled analysis of two phase 3 randomized trials (GEMINI 1 and 2). J Cataract Refract Surg. 2024 Jan 1;50(1):57-63. doi: 10.1097/j.jcrs.0000000000001313.

  PMID: 37702453 DERIVED

• Westheimer G. Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? Optom Vis Sci. 2022 Aug 1;99(8):632-634. doi: 10.1097/OPX.0000000000001924. Epub 2022 Jul 14.

  PMID: 35848990 DERIVED

• Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059.

  PMID: 35238902 DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Eleonora Safyan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: December 21, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 28, 2021
• Results First Posted: December 28, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)