Clinical trial NCT03804268: Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 323
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: A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.


Eligibility criteria: Inclusion Criteria:

- Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria:

* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery
* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
* Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
* 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

Primary outcomes:
measure: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
Secondary outcomes:
measure: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6
timeFrame: Baseline (Day 1) to Day 30 (Hour 6)
measure: Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8
timeFrame: Baseline (Day 1) to Day 30 (Hour 8)
measure: Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5
timeFrame: Baseline (Day 1) to Day 30 (Hour 0.5)
measure: Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1
timeFrame: Day 30 (Hour 1)
measure: Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
measure: Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
measure: Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10
timeFrame: Baseline (Day1) to Day 30 (Hour 10)
measure: Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25
timeFrame: Baseline (Day 1) to Day 30 (Hour 0.25)
measure: Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3
timeFrame: Day 30 (Hour 3)
measure: Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
measure: Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
measure: Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3
timeFrame: Baseline (Day 1) to Day 30 (Hour 3)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Sacramento
country: United States
facility: Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
state: California
city: Colorado Springs
country: United States
facility: Haas Vision Center
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians and Surgeons P.C.
state: Connecticut
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Delray Beach
country: United States
facility: Bruce Segal, MD
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Tampa
country: United States
facility: USF Eye Institute
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Leawood
country: United States
facility: Sabates Eye Centers
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Powell
country: United States
facility: EyeCare Professionals DWA Insight Research Clinic, LLC
state: Ohio
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
city: Cedar Park
country: United States
facility: Hill Country Eye Center
state: Texas
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: San Antonio
country: United States
facility: PNV Clinical Research LLC
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Draper
country: United States
facility: Hoopes, Durrie, Rivera Research
state: Utah
Study officials:
affiliation: Allergan
name: Eleonora Safyan
role: STUDY_DIRECTOR
References:
citation: Westheimer G. Topical Review: Pilocarpine-induced Miosis as Help for Early Presbyopes? Optom Vis Sci. 2022 Aug 1;99(8):632-634. doi: 10.1097/OPX.0000000000001924. Epub 2022 Jul 14.
citation: Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059.