Clinical trial NCT04983589: A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Keywords: Presbyopia
AGN-190584
Pilocarpine HCl 1.25%
Old Eye
Aged Eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo).

AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States.

Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

- Objective and subjective evidence of presbyopia.

Exclusion Criteria:

* Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity.
* Narrow iridocorneal angles (Shaffer grade \<=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy.
* Diagnosis of any type of glaucoma or ocular hypertension.
* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
* Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

Primary outcomes:
measure: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction
timeFrame: 3 hours after second dose on Day 14
Secondary outcomes:
measure: Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction
timeFrame: 3 hours after second dose on Day 14
measure: Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
timeFrame: 3 hours after second dose on Day 14
measure: Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction
timeFrame: 3 hours after second dose on Day 14
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye and Laser /ID# 231433
state: California
city: Glendale
country: United States
facility: Global Research Management /ID# 231300
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute /ID# 233982
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc. /ID# 231270
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 231274
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group /ID# 231332
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River /ID# 231298
state: Florida
city: Delray Beach
country: United States
facility: Bruce Segal, MD /ID# 231413
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC /ID# 231243
state: Georgia
city: Lake Villa
country: United States
facility: Jacksoneye, SC /ID# 231374
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group /ID# 231261
state: Indiana
city: Pittsburg
country: United States
facility: Kannarr Eye Care /ID# 231363
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute- Edgewood /ID# 231356
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 231275
state: Kentucky
city: Rochester
country: United States
facility: Rochester Ophthalmological Group PC /ID# 231371
state: New York
city: Memphis
country: United States
facility: Southern College of Optometry /ID# 231325
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA /ID# 231245
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research /ID# 231244
state: Tennessee
city: Cedar Park
country: United States
facility: Hill Country Eye Center /ID# 231293
state: Texas
city: El Paso
country: United States
facility: The Cataract & Glaucoma Center /ID# 231292
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 231262
state: Texas
city: Draper
country: United States
facility: Hoopes, Durrie, Rivera Research /ID# 231273
state: Utah
city: Ogden
country: United States
facility: Country Hills Eye Center /ID# 231414
state: Utah
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: