PresbyopiaPhase 3NCT04837482

A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age

A Phase 3 study testing AGN-190584 in people with Presbyopia, run by AbbVie at 1 site in Australia.

Completed

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

Trial summary

The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in disease symptoms will be assessed. 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-190584
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteAustralia
Study dates: 14 May 2021to 7 Dec 2021
Phase: Phase 3
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

In good general health at the screening visit, as determined by the investigator from medical history.
Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score > = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals.
Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder < = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit.
Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles.
Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening
Photopic, high-contrast near visual acuity correctable to 20/40 or better in each eye at the screening visit.
Mesopic pupil diameter < 8.0 mm in both eyes at the screening visit.

Who cannot join

History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study.
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
Corneal abnormalities in either eye that are likely to interfere with visual acuity.
Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy.
Diagnosis of any type of glaucoma or ocular hypertension.

Show all 11Show fewer

Females who are pregnant, nursing, or planning a pregnancy during the study.
Uncontrolled systemic disease.
Severe dry eye disease.
History of iris trauma.
Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.

Trial locations and contacts

1 site in 1 country.

Australia1 site

School of Optometry and Vision Science, Queensland University of Technology /ID# 226378
Brisbane, Queensland, 4059

Other trials in Australia

About this study

Official title: Evaluating the Impact of AGN-190584 on Night-driving Performance

AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.

This crossover study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled at 1 site in Australia.

Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days, Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days, Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires.

Conditions: Presbyopia
Being tested: AGN-190584, Vehicle
Keywords: Presbyopia, AGN-190584
Medical subject headings: Presbyopia

What participants receive

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

AGN-190584Drug
Also called Pilocarpine hydrochloride, 1.25%
Topical eyedrop
VehicleDrug
Also called Pilocarpine HCl Placebo
Topical eyedrop

Study groups in NCT04837482
Study group	Role	What they receive
AGN-190584 Sequence 1	Experimental	AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5). Receives: Drug: AGN-190584; Drug: Vehicle
AGN-190584 Sequence 2	Experimental	AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5). Receives: Drug: AGN-190584; Drug: Vehicle

What is being measured

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

Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation
An overall composite driving Z-score approximately 1 hour after study intervention instillation was derived to capture the overall driving performance of each participant compared with the whole group for the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. For each participant, the Z-score for each task of the driving test was the difference between his/her value and mean value of the assessments of all participants from the pooled data of both periods combined, divided by the standard deviation of all corresponding assessment values. Because a lower percentage of hazards hit, lower percentage of time outside of the driving lane, and a shorter lap duration indicate better driving performance, the Z-scores of these components were reversed (multiplied by -1) before computing the overall composite driving Z-score. A higher Z-score indicates better driving performance.
Measured: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Enrollment to Day 71

Timeline

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

14 May 20217 Dec 2021

First posted8 Apr 2021
Study start14 May 2021
Primary completion7 Dec 2021
Study completion7 Dec 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for PresbyopiaStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04837482
Sponsor's protocol ID: 1883-306-013
Status last verified: Sep 2024
First submitted: 6 Apr 2021
Last updated: 10 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Waring GO 4th, Brujic M, McGee S, Micheletti JM, Zhao C, Schachter S, Liu H, Safyan E. Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Clin Exp Optom. 2024 Aug;107(6):665-672. doi: 10.1080/08164622.2023.2279189. Epub 2023 Dec 3.
PubMed 38044272

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
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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Impact of AGN-190584 on Night-driving Performance
ClinicalTrials.gov ID: NCT04837482
Acronym / sponsor ID: 1883-306-013
Conditions: Presbyopia
Keywords: Presbyopia, AGN-190584
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 14 May 2021 (actual)
Primary completion: 7 Dec 2021 (actual)
Study completion: 7 Dec 2021 (actual)
First posted: 8 Apr 2021 (actual)
Results: Posted 10 Oct 2024

Clinical summary

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

AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AGN-190584 Sequence 1	Experimental	Drug: AGN-190584, Drug: VehicleAGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
AGN-190584 Sequence 2	Experimental	Drug: AGN-190584, Drug: VehicleAGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).

Who may qualify

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

Key inclusion criteria (7 listed)

In good general health at the screening visit, as determined by the investigator from medical history.
Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score > = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals.
Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder < = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit.
Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles.
Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening

Key exclusion criteria (11 listed)

History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study.
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
Corneal abnormalities in either eye that are likely to interfere with visual acuity.
Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy.

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-190584Also: Pilocarpine hydrochloride, 1.25%Topical eyedrop	Drug	AGN-190584 Sequence 1, AGN-190584 Sequence 2
VehicleAlso: Pilocarpine HCl PlaceboTopical eyedrop	Drug	AGN-190584 Sequence 1, AGN-190584 Sequence 2

Primary outcome

Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation
Time frame: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)
An overall composite driving Z-score approximately 1 hour after study intervention instillation was derived to capture the overall driving performance of each participant compared with the whole group for the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. For each participant, the Z-score for each task of the driving test was the difference between his/her value and mean value of the assessments of all participants from the pooled data of both periods combined, divided by the standard deviation of all corresponding assessment values. Because a lower percentage of hazards hit, lower percentage of time outside of the driving lane, and a shorter lap duration indicate better driving performance, the Z-scores of these components were reversed (multiplied by -1) before computing the overall composite driving Z-score. A higher Z-score indicates better driving performance.
Number of Participants With Adverse Events
Time frame: Enrollment to Day 71
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Results and safety

Results posted to the registry on 10 Oct 2024, 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 (Sequence 1)	22	22
Vehicle - AGN-190584 (Sequence 2)	21	21

Primary outcome: Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation

Time frame: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71). Mean (Standard Deviation). Unit: Z-score

Measure	Vehicle n = 43	AGN-190584 n = 42
Value	0.118 (0.4011)	-0.121 (0.4503)

Vehicle vs AGN-190584: Least-Square (LS) Mean: -0.224 (95% CI -0.346 to -0.103), p = 0.0006, Mixed Models Analysis

Population analysed: The ITT population includes all randomized participants. The primary efficacy endpoint was analyzed using a linear mixed-effects model with repeated measures (MMRM). Missing data were handled using an MMRM with the missing at random assumption, in which both missingness of data and the correlation of the repeated measurements were considered.

Primary outcome: Number of Participants With Adverse Events

Time frame: Enrollment to Day 71. Count of participants. Unit: Participants

Measure	Vehicle n = 43	AGN-190584 n = 43
Value	8	32

Population analysed: The safety population includes all treated participants who receive ≥ 1 administration of study intervention.

Adverse events

Time frame: All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1 (Vehicle)	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
Period 1 (AGN-190584)	0 of 22 (0%)	14 of 22 (63.6%)	0 of 22
Period 2 (Vehicle to AGN-190584)	0 of 21 (0%)	15 of 21 (71.4%)	0 of 21
Period 2 (AGN-190584 to Vehicle)	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38044272Waring GO 4th, Brujic M, McGee S, Micheletti JM, Zhao C, Schachter S, Liu H, Safyan E. Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Clin Exp Optom. 2024 Aug;107(6):665-672. doi: 10.1080/08164622.2023.2279189. Epub 2023 Dec 3.
Individual participant dataSharing planned: Yes. 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.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
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Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
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Recruiting
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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.

ABBVIE INC. study director

AbbVie

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AGN-190584 in people with Presbyopia, run by AbbVie at 1 site in Australia.

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 7 inclusion and 11 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Oct 2024). 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?

Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation (time frame: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)). The study lists 2 primary outcomes in all. 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 NCT04837482, which also lists 1 linked publication.

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 10 Oct 2024.