Clinical trial NCT05393089: Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Presbyopia
Keywords: Presbyopia
Pseudophakic Presbyopia
AGN-190584
ARIES
Pilocarpine HCl
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group /ID# 243541
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center /ID# 243897
state: Arizona
city: Glendale
country: United States
facility: Global Research Management /ID# 243544
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute /ID# 243531
state: California
city: Newport Beach
country: United States
facility: Salvay Vision /ID# 243828
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 243524
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants /ID# 243538
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River /ID# 243519
state: Florida
city: Delray Beach
country: United States
facility: Segal Drug Trials, Inc /ID# 243521
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Meyers /ID# 243545
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates Inc. /ID# 243532
state: Florida
city: Atlanta
country: United States
facility: Emory University /ID# 243534
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC /ID# 243530
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates /ID# 243525
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr Eye Care /ID# 243542
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute- Edgewood /ID# 243810
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 243588
state: Kentucky
city: Fraser
country: United States
facility: Fraser Eye Center /ID# 244038
state: Michigan
city: Kansas City
country: United States
facility: Silverstein Eye Centers /ID# 243546
state: Missouri
city: Dover
country: United States
facility: Eye Associates of North Jersey /ID# 243913
state: New Jersey
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute PA /ID# 243522
state: New Jersey
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PC /ID# 243539
state: New York
city: Powell
country: United States
facility: EyeCare Professionals Inc /ID# 243938
state: Ohio
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 243548
state: Pennsylvania
city: Maryville
country: United States
facility: University Eye Surgeons /ID# 243926
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research /ID# 243529
state: Tennessee
city: Dallas
country: United States
facility: Key-Whitman Eye Center /ID# 243928
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 243526
state: Texas
city: San Antonio
country: United States
facility: Parkhurst Nuvision /ID# 244041
state: Texas
city: Draper
country: United States
facility: Hoopes, Durrie, Rivera Research /ID# 243535
state: Utah
city: Ogden
country: United States
facility: Country Hills Eye Center /ID# 243520
state: Utah
city: Saint George
country: United States
facility: Southern Utah Medical Research /ID# 243931
state: Utah
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: