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

Presbyopia Clinical Trial

— ARIES  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05393089
• Other study ID #: M21-194
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 9, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: June 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• AGN-190584
Eye drops
• Vehicle
Eye drops

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 14 days