PresbyopiaPhase 2ARIESNCT05393089
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
A Phase 2 study testing AGN-190584 in people with Presbyopia, run by Allergan at 32 sites in United States.
Trial summary
Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- AGN-190584
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 32 sitesUnited States
- Study dates
- 9 Jun 2022to 4 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
- If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
- 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 25-Item National Eye Institute Visual Function Questionnaire (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.
- Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
- Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.
Who cannot join
- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Emory University /ID# 243534
Atlanta, Georgia, 30322-1013
Arizona Eye Center /ID# 243897
Chandler, Arizona, 85224
Scott and Christie and Associates /ID# 243548
Cranberry Township, Pennsylvania, 16066
Nature Coast Clinical Research - Crystal River /ID# 243519
Crystal River, Florida, 34429
Key-Whitman Eye Center /ID# 243928
Dallas, Texas, 75243
Segal Drug Trials, Inc /ID# 243521
Delray Beach, Florida, 33484
Trinity Research Group /ID# 243541
Dothan, Alabama, 36301
Eye Associates of North Jersey /ID# 243913
Dover, New Jersey, 07801-1629
Hoopes, Durrie, Rivera Research /ID# 243535
Draper, Utah, 84020-7133
Cincinnati Eye Institute- Edgewood /ID# 243810
Edgewood, Kentucky, 41017-3415
Eye Associates of Fort Meyers /ID# 243545
Fort Myers, Florida, 33901
Fraser Eye Center /ID# 244038
Fraser, Michigan, 48026
Global Research Management /ID# 243544
Glendale, California, 91204-2500
United Medical Research Institute /ID# 243531
Inglewood, California, 90301
Levenson Eye Associates Inc. /ID# 243532
Jacksonville, Florida, 32204
Silverstein Eye Centers /ID# 243546
Kansas City, Missouri, 64034
The Eye Care Institute /ID# 243588
Louisville, Kentucky, 40206-1738
University Eye Surgeons /ID# 243926
Maryville, Tennessee, 37805
Clayton Eye Clinical Research, LLC /ID# 243530
Morrow, Georgia, 30260-4180
Salvay Vision /ID# 243828
Newport Beach, California, 92663-3600
The Eye Research Foundation /ID# 243524
Newport Beach, California, 92663-3637
Country Hills Eye Center /ID# 243520
Ogden, Utah, 84403-2200
Kannarr Eye Care /ID# 243542
Pittsburg, Kansas, 66762-2620
EyeCare Professionals Inc /ID# 243938
Powell, Ohio, 43065
Rochester Ophthalmological Group PC /ID# 243539
Rochester, New York, 14618-2616
Coastal Research Associates /ID# 243525
Roswell, Georgia, 30076
Sacramento Eye Consultants /ID# 243538
Sacramento, California, 95815
Eye associates /ID# 243526
San Antonio, Texas, 78229
Parkhurst Nuvision /ID# 244041
San Antonio, Texas, 78229
Advancing Vision Research /ID# 243529
Smyrna, Tennessee, 37167
Northern New Jersey Eye Institute PA /ID# 243522
South Orange, New Jersey, 07079-1855
Southern Utah Medical Research /ID# 243931
St. George, Utah, 84790
About this study
Official title: A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia
Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.
AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.
Read more
Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.
- Conditions
- Presbyopia
- Being tested
- AGN-190584, Vehicle
- Keywords
- Presbyopia, Pseudophakic Presbyopia, AGN-190584, ARIES, Pilocarpine HCl
- 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
Eye drops
VehicleDrug
Eye drops
| Study group | Role | What they receive |
|---|---|---|
| AGN-190584 | Experimental | Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days. Receives: Drug: AGN-190584 |
| Vehicle | Placebo comparator | Participants will receive one drop of vehicle instilled in each eye once daily for 14 days. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start9 Jun 2022 (estimated)
- Primary completion4 Apr 2023 (estimated)
- Study completion4 Apr 2023 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393089
- Sponsor's protocol ID
- M21-194
- Acronym
- ARIES
- Status last verified
- Jun 2022
- First submitted
- 23 May 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- 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 and 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. 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 and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia
- ClinicalTrials.gov ID
- NCT05393089
- Acronym / sponsor ID
- ARIES / M21-194
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Pseudophakic Presbyopia, AGN-190584, ARIES, Pilocarpine HCl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (estimated)
- Primary completion
- 4 Apr 2023 (estimated)
- Study completion
- 4 Apr 2023 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.
AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.
Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGN-190584 | Experimental | Drug: AGN-190584Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days. |
| Vehicle | Placebo comparator | Drug: VehicleParticipants will receive one drop of vehicle instilled in each eye once daily for 14 days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
- If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
- 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 25-Item National Eye Institute Visual Function Questionnaire (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.
- Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
- Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.
Key exclusion criteria (1 listed)
- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).
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-190584Eye drops | Drug | AGN-190584 |
| VehicleEye drops | Drug | Vehicle |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 14 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- 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 and 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.
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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.
ALLERGAN INC. study director
Allergan
32 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-190584 in people with Presbyopia, run by Allergan at 32 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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2022.