Virgo: 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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT04983589
Collaborator
(none)
230
23
2
5.3
10
1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 2, 2021
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AGN-190584

One drop bilaterally twice daily for 14 days.

Drug: AGN-190584
Ocular drops
Other Names:
  • Pilocarpine HCl 1.25%
  • Placebo Comparator: Vehicle

    One drop bilaterally twice daily for 14 days.

    Drug: Vehicle
    Ocular drops

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Day 14]

      Both near vision and distance vision are measured to evaluate the effect of AGN-190584.

    Secondary Outcome Measures

    1. 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 [Day 14]

      Both near vision and distance vision are measured to evaluate the effect of AGN-190584.

    2. 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 [Day 14]

      Both near vision and distance vision are measured to evaluate the effect of AGN-190584.

    3. 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 [Day 14]

      Both near vision and distance vision are measured to evaluate the effect of AGN-190584.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: ALLERGAN INC., Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04983589
    Other Study ID Numbers:
    • M21-195
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Allergan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 2, 2022