PresbyopiaPhase 2NCT02780115

A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

A Phase 2 study testing AGN-199201 ophthalmic solution and AGN-190584 ophthalmic solution in people with Presbyopia, run by Allergan at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up). Read more about this study

Who is it for?: Ages 40 to 55 years
Conditions the study is for: Presbyopia
What is being tested?: AGN-199201 ophthalmic solution and AGN-190584 ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 25 sitesUnited States
Study dates: 26 May 2016to 31 Oct 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Retina Institute of California Medical Group
Arcadia, California, 91007
Sall Research Medical Center
Artesia, California, 90701
Specialized Eye Care
Baltimore, Maryland, 21210
Medical University of South Carolina
Charleston, South Carolina, 29425
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
WCCT Global, LLC
Cypress, California, 90630
Hoopes Durrie Rivera Research, LLC
Draper, Utah, 84020
Cataract and Glaucoma Center
El Paso, Texas, 79902
University of Texas Medical Branch
Galveston, Texas, 77555
Specialty Eye Care Medical Center
Glendale, California, 91203
Lugene Eye Institute
Glendale, California, 91204
Silverstein Eye Centers
Louisville, Kentucky, 40206
The Eye Care Institute
Louisville, Kentucky, 40206
Total Eye Care, PA
Memphis, Tennessee, 38119
MedEye Associates
Miami, Florida, 33143
Clayton Eye Center
Morrow, Georgia, 30260
The Eye Research Foundation
Newport Beach, California, 92663
Central Florida Eye Institute
Ocala, Florida, 34474
Stanford Eye and Laser Center
Palo Alto, California, 94303
Devers Eye Institute
Portland, Oregon, 97210
R and R Eye Research, LLC
San Antonio, Texas, 78229
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Center for Sight
Sarasota, Florida, 34239
Wolstan and Golberg Eye Associates
Torrance, California, 90505
James D. Branch
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Conditions: Presbyopia
Being tested: AGN-199201 ophthalmic solution, AGN-190584 ophthalmic solution, AGN-199201 Vehicle, AGN-190584 Vehicle
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGN-199201 ophthalmic solutionDrug
1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
AGN-190584 ophthalmic solutionDrug
1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
AGN-199201 VehicleDrug
Vehicle to AGN-199201
AGN-190584 VehicleDrug
Vehicle to AGN-190584

Study groups in NCT02780115
Study group	Role	What they receive
Cohort 1: Vehicle Control	Experimental	Vehicle dosed in both eyes administered once daily during office visits 1 through 5. Receives: Drug: AGN-199201 Vehicle; Drug: AGN-190584 Vehicle
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A	Experimental	Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B	Experimental	Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C	Experimental	Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C	Experimental	Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-199201 Vehicle; Drug: AGN-190584 Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
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.
Measured: Baseline, Day 28

Secondary outcomes (1)

Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Measured: up to 65 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 201631 Oct 2017

First posted23 May 2016 (estimated)
Study start26 May 2016
Primary completion31 Oct 2017
Study completion31 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02780115
Sponsor's protocol ID: 199201-010
Status last verified: Nov 2020
First submitted: 19 May 2016
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y.
PubMed 34855038
Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13.
PubMed 34643894

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients With Presbyopia
ClinicalTrials.gov ID: NCT02780115
Acronym / sponsor ID: 199201-010
Conditions: Presbyopia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 26 May 2016 (actual)
Primary completion: 31 Oct 2017 (actual)
Study completion: 31 Oct 2017 (actual)
First posted: 23 May 2016 (estimated)
Results: Posted 22 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Cohort 1: Vehicle Control	Experimental	Drug: AGN-199201 Vehicle, Drug: AGN-190584 VehicleVehicle dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solutionFixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solutionFixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solutionFixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5.
Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solution, Drug: AGN-199201 Vehicle, Drug: AGN-190584 VehicleDominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.

Who may qualify

Ages: 40 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGN-199201 ophthalmic solution1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.	Drug	Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A, Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B, Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C, Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
AGN-190584 ophthalmic solution1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.	Drug	Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A, Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B, Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C, Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
AGN-199201 VehicleVehicle to AGN-199201	Drug	Cohort 1: Vehicle Control, Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C
AGN-190584 VehicleVehicle to AGN-190584	Drug	Cohort 1: Vehicle Control, Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C

Primary outcome

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye
Time frame: Baseline, Day 28
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.

1 secondary outcome

Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 65 days

Results and safety

Results posted to the registry on 22 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Vehicle Control	28	28
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose	30	29
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose	30	29
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose	32	31
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose	31	30

Primary outcome: Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye

Time frame: Baseline, Day 28. Least squares mean (Standard Error). Unit: letters correctly read

Measure	Cohort 1: Vehicle Control n = 28	Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose n = 30	Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose n = 30	Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose n = 32	Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose n = 31
Value	3.00 (1.03)	4.96 (1.00)	7.77 (1.00)	7.54 (0.97)	7.81 (1.02)

Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose: LS Mean Diff: 1.96 (95% CI -0.83 to 4.74), p = 0.1663, ANCOVA
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose: LS Mean Diff: 4.77 (95% CI 1.98 to 7.56), p = 0.0009, ANCOVA
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose: LS Mean Diff: 4.54 (95% CI 1.79 to 7.29), p = 0.0014, ANCOVA

Population analysed: Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected for up to 65 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Vehicle Control	0 of 28 (0%)	7 of 28 (25%)	0 of 28
Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose	0 of 30 (0%)	8 of 30 (26.7%)	0 of 30
Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose	0 of 30 (0%)	10 of 30 (33.3%)	0 of 30
Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose	0 of 32 (0%)	11 of 32 (34.4%)	0 of 32
Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose	0 of 31 (0%)	7 of 31 (22.6%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34855038Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y.
Derived from this study: PubMed 34643894Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13.

Related trials for Presbyopia

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Clinical Trial With Artiflex Presbyopic (Artiplus)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haixia Liu study director

Allergan

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGN-199201 ophthalmic solution and AGN-190584 ophthalmic solution in people with Presbyopia, run by Allergan at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye (time frame: Baseline, Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02780115, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.