PresbyopiaPhase 2NCT02595528

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

A Phase 2 study testing AGN-199201 ophthalmic solution, AGN-190584 ophthalmic solution and AGN-199201 + AGN-190584 Combination in people with Presbyopia, run by Allergan at 20 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 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). Read more about this study

Who is it for?: Ages 40 to 50 years
Conditions the study is for: Presbyopia
What is being tested?: AGN-199201 ophthalmic solution, AGN-190584 ophthalmic solution and AGN-199201 + AGN-190584 Combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 20 sitesUnited States
Study dates: 29 Apr 2016to 18 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 50 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

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia

Conditions: Presbyopia
Being tested: AGN-199201 ophthalmic solution, AGN-190584 ophthalmic solution, AGN-190584 vehicle, AGN-199201 + AGN-190584 Combination, AGN-199201 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 AGN-190584 ophthalmic solution doses A, B and C in the eye.
AGN-190584 vehicleDrug
Vehicle to AGN-190584
AGN-199201 + AGN-190584 CombinationDrug
1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
AGN-199201 vehicleDrug
Vehicle to AGN-199201

Study groups in NCT02595528
Study group	Role	What they receive
AGN-199201 and AGN-190584 Vehicle	Experimental	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. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-190584 vehicle; Drug: AGN-199201 + AGN-190584 Combination; Drug: AGN-199201 vehicle
AGN-199201 and AGN-190584 Dose A	Experimental	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. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-190584 vehicle; Drug: AGN-199201 + AGN-190584 Combination; Drug: AGN-199201 vehicle
AGN-199201 and AGN-190584 Dose B	Experimental	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. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-190584 vehicle; Drug: AGN-199201 + AGN-190584 Combination; Drug: AGN-199201 vehicle
AGN-199201 and AGN-190584 Dose C	Experimental	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. Receives: Drug: AGN-199201 ophthalmic solution; Drug: AGN-190584 ophthalmic solution; Drug: AGN-190584 vehicle; Drug: AGN-199201 + AGN-190584 Combination; Drug: AGN-199201 vehicle

What is being measured

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

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

Timeline

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

29 Apr 201618 Oct 2017

First posted3 Nov 2015 (estimated)
Study start29 Apr 2016
Primary completion18 Oct 2017
Study completion18 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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595528
Sponsor's protocol ID: 199201-009
Status last verified: Nov 2020
First submitted: 2 Nov 2015
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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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Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
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Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
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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, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia
ClinicalTrials.gov ID: NCT02595528
Acronym / sponsor ID: 199201-009
Conditions: Presbyopia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 29 Apr 2016 (actual)
Primary completion: 18 Oct 2017 (actual)
Study completion: 18 Oct 2017 (actual)
First posted: 3 Nov 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AGN-199201 and AGN-190584 Vehicle	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solution, Drug: AGN-190584 vehicle, Drug: AGN-199201 + AGN-190584 Combination, Drug: AGN-199201 vehicleParticipants 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.
AGN-199201 and AGN-190584 Dose A	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solution, Drug: AGN-190584 vehicle, Drug: AGN-199201 + AGN-190584 Combination, Drug: AGN-199201 vehicleParticipants 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.
AGN-199201 and AGN-190584 Dose B	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solution, Drug: AGN-190584 vehicle, Drug: AGN-199201 + AGN-190584 Combination, Drug: AGN-199201 vehicleParticipants 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.
AGN-199201 and AGN-190584 Dose C	Experimental	Drug: AGN-199201 ophthalmic solution, Drug: AGN-190584 ophthalmic solution, Drug: AGN-190584 vehicle, Drug: AGN-199201 + AGN-190584 Combination, Drug: AGN-199201 vehicleParticipants 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.

Who may qualify

Ages: 40 to 50 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	AGN-199201 and AGN-190584 Dose A, AGN-199201 and AGN-190584 Dose B, AGN-199201 and AGN-190584 Dose C, AGN-199201 and AGN-190584 Vehicle
AGN-190584 ophthalmic solution1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.	Drug	AGN-199201 and AGN-190584 Dose A, AGN-199201 and AGN-190584 Dose B, AGN-199201 and AGN-190584 Dose C, AGN-199201 and AGN-190584 Vehicle
AGN-190584 vehicleVehicle to AGN-190584	Drug	AGN-199201 and AGN-190584 Dose A, AGN-199201 and AGN-190584 Dose B, AGN-199201 and AGN-190584 Dose C, AGN-199201 and AGN-190584 Vehicle
AGN-199201 + AGN-190584 Combination1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.	Drug	AGN-199201 and AGN-190584 Dose A, AGN-199201 and AGN-190584 Dose B, AGN-199201 and AGN-190584 Dose C, AGN-199201 and AGN-190584 Vehicle
AGN-199201 vehicleVehicle to AGN-199201	Drug	AGN-199201 and AGN-190584 Dose A, AGN-199201 and AGN-190584 Dose B, AGN-199201 and AGN-190584 Dose C, AGN-199201 and AGN-190584 Vehicle

Primary outcome

Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters
Time frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods
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.

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
AGN-190584 Vehicle and AGN-199201	41	39
AGN-190584 Lower Dose and AGN-199201	40	37
AGN-190584 Medium Dose and AGN-199201	42	41
AGN-190584 Higher Dose and AGN-199201	40	36

Primary outcome: Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters

Time frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods. Least squares mean (Standard Error). Unit: letters correctly read

Measure	AGN-190584 Vehicle n = 40	AGN-190584 Lower Dose n = 37	AGN-190584 Medium Dose n = 42	AGN-190584 Higher Dose n = 38
AGN-199201 Vehicle	1.12 (0.48)	3.83 (0.37)	5.26 (0.37)	5.42 (0.50)
AGN-199201 Lower Dose	1.24 (0.44)	3.94 (0.34)	5.37 (0.34)	5.52 (0.46)
AGN-199201 Medium Dose	1.47 (0.47)	4.16 (0.39)	5.56 (0.39)	5.70 (0.48)
AGN-199201 Higher Dose	1.34 (0.55)	3.99 (0.41)	5.36 (0.40)	5.46 (0.56)

AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose: Least Squares (LS): -2.5543, p = 0.0029, Mixed model for repeated measures
AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose: Least Squares (LS): 6.6961, p <0.0001, Mixed model for repeated measures
AGN-190584 Vehicle vs AGN-190584 Lower Dose vs AGN-190584 Medium Dose vs AGN-190584 Higher Dose: Least Squares (LS): -69.890, p = 0.4126, Mixed model for repeated measures

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.

Adverse events

Time frame: Adverse events were collected for 112 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN-190584 Vehicle and AGN-199201	1 of 41 (2.4%)	9 of 41 (22%)	0 of 41
AGN-190584 Lower Dose and AGN-199201	1 of 39 (2.6%)	9 of 39 (23.1%)	0 of 39
AGN-190584 Medium Dose and AGN-199201	0 of 42 (0%)	16 of 42 (38.1%)	0 of 42
AGN-190584 Higher Dose and AGN-199201	1 of 39 (2.6%)	17 of 39 (43.6%)	0 of 39

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.

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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

20 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, AGN-190584 ophthalmic solution and AGN-199201 + AGN-190584 Combination in people with Presbyopia, run by Allergan at 20 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 20 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 Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters (time frame: Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods). 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 NCT02595528.

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.