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 (Virgo)

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: Vehicle; Drug: Pilocarpine HCl

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309-0637
      • Empire Eye and Laser /ID# 231433
    • Glendale, California, United States, 91204-2500
      • Global Research Management /ID# 231300
    • Inglewood, California, United States, 90301
      • United Medical Research Institute /ID# 233982
    • Mission Hills, California, United States, 91345-1200
      • North Valley Eye Medical Group, Inc. /ID# 231270
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 231274
    • Rancho Cordova, California, United States, 95670-2968
      • Martel Eye Medical Group /ID# 231332
  • Florida
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research - Crystal River /ID# 231298
    • Delray Beach, Florida, United States, 33484-6540
      • Bruce Segal, MD /ID# 231413
  • Georgia
    • Morrow, Georgia, United States, 30260-4180
      • Clayton Eye Clinical Research, LLC /ID# 231243
  • Illinois
    • Lake Villa, Illinois, United States, 60046-8563
      • Jacksoneye, SC /ID# 231374
  • Indiana
    • Indianapolis, Indiana, United States, 46260-5381
      • Price Vision Group /ID# 231261
  • Kansas
    • Pittsburg, Kansas, United States, 66762-2620
      • Kannarr Eye Care /ID# 231363
  • Kentucky
    • Edgewood, Kentucky, United States, 41017-3415
      • Cincinnati Eye Institute- Edgewood /ID# 231356
    • Louisville, Kentucky, United States, 40206-1738
      • The Eye Care Institute /ID# 231275
  • New York
    • Rochester, New York, United States, 14618-2616
      • Rochester Ophthalmological Group PC /ID# 231371
  • Tennessee
    • Memphis, Tennessee, United States, 38104-2211
      • Southern College of Optometry /ID# 231325
    • Memphis, Tennessee, United States, 38119-5745
      • Total Eye Care, PA /ID# 231245
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research /ID# 231244
  • Texas
    • Cedar Park, Texas, United States, 78613-7651
      • Hill Country Eye Center /ID# 231293
    • El Paso, Texas, United States, 79902-1444
      • The Cataract & Glaucoma Center /ID# 231292
    • San Antonio, Texas, United States, 78229
      • Eye associates /ID# 231262
  • Utah
    • Draper, Utah, United States, 84020-7133
      • Hoopes, Durrie, Rivera Research /ID# 231273
    • Ogden, Utah, United States, 84403-2200
      • Country Hills Eye Center /ID# 231414

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Objective and subjective evidence of presbyopia.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days.	Drug: Vehicle; Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Experimental: AGN-190584; AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.	Drug: Pilocarpine HCl; Pilocarpine HCl ophthalmic solution 1.25% ocular drops.; Other Names: AGN-190584

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction	Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction	Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in photopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (≥ 251 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in photopic, high contrast, binocular DCNVA with no more than 5-letter loss in photopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14
Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction	Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 2 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14
Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction	Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who achieved 20/40 or better in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Presbyopia; AGN-190584; Pilocarpine HCl 1.25%; Old Eye; Aged Eye
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: M21-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes