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CompletedNCT02595528Updated Dec 22, 2020Results posted

A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

A Phase 2 interventional study of AGN-199201 ophthalmic solution and AGN-190584 ophthalmic solution in Presbyopia, sponsored by Allergan. Completed at 20 sites in United States. Open to participants aged 40 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-12-22.

Sponsored by Allergan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
40 Years to 50 Years
Sex
All
01

Study summary

This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's enrollment of 163 is above the median of 61 across 265 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living.

Exclusion criteria

Exclusion Criteria:

  • Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
  • Corneal abnormalities in either eye that interfere with visual acuity
  • History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
  • Diagnosis of glaucoma or ocular hypertension.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
163 participants (actual)

Study arms

  • Experimental
    AGN-199201 and AGN-190584 Vehicle

    Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

    Drug: AGN-199201 ophthalmic solution · Drug: AGN-190584 ophthalmic solution · Drug: AGN-190584 vehicle · Drug: AGN-199201 + AGN-190584 Combination · Drug: AGN-199201 vehicle

  • Experimental
    AGN-199201 and AGN-190584 Dose A

    Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

    Drug: AGN-199201 ophthalmic solution · Drug: AGN-190584 ophthalmic solution · Drug: AGN-190584 vehicle · Drug: AGN-199201 + AGN-190584 Combination · Drug: AGN-199201 vehicle

  • Experimental
    AGN-199201 and AGN-190584 Dose B

    Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

    Drug: AGN-199201 ophthalmic solution · Drug: AGN-190584 ophthalmic solution · Drug: AGN-190584 vehicle · Drug: AGN-199201 + AGN-190584 Combination · Drug: AGN-199201 vehicle

  • Experimental
    AGN-199201 and AGN-190584 Dose C

    Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle.

    Drug: AGN-199201 ophthalmic solution · Drug: AGN-190584 ophthalmic solution · Drug: AGN-190584 vehicle · Drug: AGN-199201 + AGN-190584 Combination · Drug: AGN-199201 vehicle

Interventions

  • DrugAGN-199201 ophthalmic solution

    1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.

  • DrugAGN-190584 ophthalmic solution

    1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.

  • DrugAGN-190584 vehicle

    Vehicle to AGN-190584

  • DrugAGN-199201 + AGN-190584 Combination

    1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.

  • DrugAGN-199201 vehicle

    Vehicle to AGN-199201

06

What researchers measure

Primary outcomes

  1. Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

    UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.

    Time frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods

07

Results

Posted Dec 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneAGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201
Started41404240
Completed39374136
Not completed2314
Withdrew: Withdrawal by subject1213
Withdrew: Lost to follow-up1101

Outcome measures

PrimaryWeighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.

Time frame:
Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods
Reported as:
Least squares mean · letters correctly read
Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
letters correctly readAGN-190584 VehicleAGN-190584 Lower DoseAGN-190584 Medium DoseAGN-190584 Higher Dose
AGN-199201 Vehicle1.12 ± 0.483.83 ± 0.375.26 ± 0.375.42 ± 0.50
AGN-199201 Lower Dose1.24 ± 0.443.94 ± 0.345.37 ± 0.345.52 ± 0.46
AGN-199201 Medium Dose1.47 ± 0.474.16 ± 0.395.56 ± 0.395.70 ± 0.48
AGN-199201 Higher Dose1.34 ± 0.553.99 ± 0.415.36 ± 0.405.46 ± 0.56
Statistical analysis
  • AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose · Mixed model for repeated measures · p = 0.0029 · Least squares (ls): -2.5543
  • AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose · Mixed model for repeated measures · p = <0.0001 · Least squares (ls): 6.6961
  • AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose · Mixed model for repeated measures · p = 0.4126 · Least squares (ls): -69.890
  • AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose · Mixed model for repeated measures · p = 0.3752 · Least squares (ls): 10.5017

Adverse events

Collected over Adverse events were collected for 112 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AGN-190584 Vehicle and AGN-1992010/41 (0%)1/41 (2.4%)9/41 (22%)
AGN-190584 Lower Dose and AGN-1992010/39 (0%)1/39 (2.6%)9/39 (23.1%)
AGN-190584 Medium Dose and AGN-1992010/42 (0%)0/42 (0%)16/42 (38.1%)
AGN-190584 Higher Dose and AGN-1992010/39 (0%)1/39 (2.6%)17/39 (43.6%)
Most frequent serious events
Most frequent serious events
EventAGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201
CholecystitisHepatobiliary disorders0/411/390/420/39
Malignant melanomaMusculoskeletal and connective tissue disorders0/410/390/421/39
Cervix carcinoma stage 0Investigations1/410/390/420/39
Most frequent other events
Most frequent other events
EventAGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201
HeadacheNervous system disorders5/414/398/427/39
Visual impairmentEye disorders1/410/391/424/39
Punctate keratitisEye disorders2/411/394/422/39
Instillation site painGeneral disorders3/410/391/423/39
Lacrimation increasedEye disorders0/413/392/420/39
Upper respiratory tract infectionInfections and infestations0/412/393/421/39
Foreign body sensation in eyesEye disorders1/412/390/420/39
Visual acuity reducedEye disorders0/410/391/422/39
Vitreous floatersEye disorders0/410/390/422/39

Baseline characteristics

Safety Population: all subjects who received ≥ 1 administration of study treatment

Age, Continuous
Age, Continuous(Years)AGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201Total
Mean46.6 ± 2.947.1 ± 2.746.8 ± 2.846.7 ± 2.346.8 ± 2.6
Sex: Female, Male
Sex: Female, Male(Participants)AGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201Total
Female32272924112
Male912131549
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201Total
Hispanic or Latino7113930
Not Hispanic or Latino34283930131
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201Total
American Indian or Alaska Native01102
Asian31004
Native Hawaiian or Other Pacific Islander00000
Black or African American6613328
White32302836126
More than one race01001
Unknown or Not Reported00000
Baseline UNVA severity
Baseline UNVA severity(Participants)AGN-190584 Vehicle and AGN-199201AGN-190584 Lower Dose and AGN-199201AGN-190584 Medium Dose and AGN-199201AGN-190584 Higher Dose and AGN-199201Total
≤ 20/8026282826108
> 20/801511141353
08

Study locations

20 sites
  • Sall Research Medical Center
    Artesia, California 90701, United States
  • Milton M. Hom, OD, FAAO
    Azusa, California 91702, United States
  • WCCT Global, LLC
    Costa Mesa, California 92626, United States
  • The Eye Research Foundation
    Newport Beach, California 92663, United States
  • North Bay Eye Associates, Inc.
    Petaluma, California 94954, United States
  • Martel Eye Medical Group
    Rancho Cordova, California 95670, United States
  • West Coast Eye Care
    San Diego, California 92115, United States
  • Corneal Consultants of Colorado, P.C.
    Littleton, Colorado 80120, United States
  • Mid Florida Eye Center
    Mount Dora, Florida 32757, United States
  • Clayton Eye Center
    Morrow, Georgia 30260, United States
  • Price Vision Group
    Indianapolis, Indiana 46260, United States
  • Specialized Eye Care
    Baltimore, Maryland 21210, United States
  • Comprehensive Eye Care, Ltd
    Washington, Missouri 63090, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, United States
  • Scott & Christie and Associates, PC
    Cranberry Township, Pennsylvania 16066, United States
  • Total Eye Care, PA
    Memphis, Tennessee 38119, United States
  • Cataract and Glaucoma Center
    El Paso, Texas 79902, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
  • Hoopes Durrie Rivera Research, LLC
    Draper, Utah 84020, United States
  • The Eye Centers of Racine & Kenosha
    Kenosha, Wisconsin 53142, United States
09

References and documents

Study documents

  • Statistical analysis plan · Nov 9, 2017
  • Study protocol · Apr 4, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02595528
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Nov 3, 2015
Start date
Apr 29, 2016
Primary completion
Oct 18, 2017
Completion
Oct 18, 2017
Results posted
Dec 22, 2020
Last update
Dec 22, 2020

Study contacts

Haixia Liu
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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