ARIES: Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia

Sponsor

Allergan (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT05393089

Collaborator

(none)

Enrollment

Locations

Arms

9.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: AGN-190584 Drug: Vehicle	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 9, 2022

Anticipated Primary Completion Date :

Apr 4, 2023

Anticipated Study Completion Date :

Apr 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-190584 Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.	Drug: AGN-190584 Eye drops
Placebo Comparator: Vehicle Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.	Drug: Vehicle Eye drops

Arm

Intervention/Treatment

Experimental: AGN-190584

Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.

Drug: AGN-190584

Eye drops

Placebo Comparator: Vehicle

Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.

Drug: Vehicle

Eye drops

Outcome Measures

Primary Outcome Measures

Number of Participants Experiencing Adverse Events (AEs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Research Group /ID# 243541	Dothan	Alabama	United States	36301
2	Arizona Eye Center /ID# 243897	Chandler	Arizona	United States	85224
3	Global Research Management /ID# 243544	Glendale	California	United States	91204-2500
4	United Medical Research Institute /ID# 243531	Inglewood	California	United States	90301
5	Salvay Vision /ID# 243828	Newport Beach	California	United States	92663-3600
6	The Eye Research Foundation /ID# 243524	Newport Beach	California	United States	92663-3637
7	Sacramento Eye Consultants /ID# 243538	Sacramento	California	United States	95815
8	Nature Coast Clinical Research - Crystal River /ID# 243519	Crystal River	Florida	United States	34429
9	Segal Drug Trials, Inc /ID# 243521	Delray Beach	Florida	United States	33484
10	Eye Associates of Fort Meyers /ID# 243545	Fort Myers	Florida	United States	33901
11	Levenson Eye Associates Inc. /ID# 243532	Jacksonville	Florida	United States	32204
12	Emory University /ID# 243534	Atlanta	Georgia	United States	30322-1013
13	Clayton Eye Clinical Research, LLC /ID# 243530	Morrow	Georgia	United States	30260-4180
14	Coastal Research Associates /ID# 243525	Roswell	Georgia	United States	30076
15	Kannarr Eye Care /ID# 243542	Pittsburg	Kansas	United States	66762-2620
16	Cincinnati Eye Institute- Edgewood /ID# 243810	Edgewood	Kentucky	United States	41017-3415
17	The Eye Care Institute /ID# 243588	Louisville	Kentucky	United States	40206-1738
18	Fraser Eye Center /ID# 244038	Fraser	Michigan	United States	48026
19	Silverstein Eye Centers /ID# 243546	Kansas City	Missouri	United States	64034
20	Eye Associates of North Jersey /ID# 243913	Dover	New Jersey	United States	07801-1629
21	Northern New Jersey Eye Institute PA /ID# 243522	South Orange	New Jersey	United States	07079-1855
22	Rochester Ophthalmological Group PC /ID# 243539	Rochester	New York	United States	14618-2616
23	EyeCare Professionals Inc /ID# 243938	Powell	Ohio	United States	43065
24	Scott and Christie and Associates /ID# 243548	Cranberry Township	Pennsylvania	United States	16066
25	University Eye Surgeons /ID# 243926	Maryville	Tennessee	United States	37805
26	Advancing Vision Research /ID# 243529	Smyrna	Tennessee	United States	37167
27	Key-Whitman Eye Center /ID# 243928	Dallas	Texas	United States	75243
28	Eye associates /ID# 243526	San Antonio	Texas	United States	78229
29	Parkhurst Nuvision /ID# 244041	San Antonio	Texas	United States	78229
30	Hoopes, Durrie, Rivera Research /ID# 243535	Draper	Utah	United States	84020-7133
31	Country Hills Eye Center /ID# 243520	Ogden	Utah	United States	84403-2200
32	Southern Utah Medical Research /ID# 243931	Saint George	Utah	United States	84790

Sponsors and Collaborators

Allergan

Investigators

Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allergan

ClinicalTrials.gov Identifier:

NCT05393089

Other Study ID Numbers:

M21-194

First Posted:

May 26, 2022

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Allergan

Presbyopia

Pseudophakic Presbyopia

AGN-190584

ARIES

Pilocarpine HCl

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Jun 29, 2022