Clinical trial NCT03857542: A Phase 3 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: 2019-02-28
Enrollment: 427
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: This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.


Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

Uncontrolled systemic disease

Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll.

Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications

Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study

Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes

Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

Participation in a blood or plasma donation program within 30 days prior to study intervention administration

Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit

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

History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit

Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy

Diagnosis of any type of glaucoma or ocular hypertension

Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled

Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history

Females who are pregnant, nursing, or planning a pregnancy during the study

Primary outcomes:
measure: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction 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 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 (Day 1) 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 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: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Prescott
country: United States
facility: M&M Eye Institute
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center
state: Arizona
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado
state: Colorado
city: Crystal River
country: United States
facility: Benjamin Knox Lambright, MD
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Vision Center
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye Associates
state: Florida
city: Mount Dora
country: United States
facility: Mid Florida Eye Center
state: Florida
city: Sebring
country: United States
facility: Newsom Eye & Laser Center
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Des Plaines
country: United States
facility: The Midwest Center for Sight
state: Illinois
city: Lake Villa
country: United States
facility: Jacksoneye
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Shawnee Mission
country: United States
facility: Heart of America Eyecare
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Bloomington
country: United States
facility: Chu Laser Eye Institute
state: Minnesota
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Las Vegas
country: United States
facility: Amel Youssef, OD
state: Nevada
city: Las Vegas
country: United States
facility: Debry Medical Services PC
state: Nevada
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Waring Vision Institute
state: South Carolina
city: Maryville
country: United States
facility: University Eye Surgeons
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Austin
country: United States
facility: Keystone Research ltd. at Texan Eye
state: Texas
city: El Paso
country: United States
facility: The Cataract and Glaucoma Center
state: Texas
city: Hurst
country: United States
facility: Texas Eye & Laser Ctr
state: Texas
city: Ogden
country: United States
facility: Benjamin Travis Dastrup, MD
state: Utah
city: Falls Church
country: United States
facility: Vision Consultants and Surgeons
state: Virginia
Study officials:
affiliation: Allergan
name: Eleonora Safyan
role: STUDY_DIRECTOR
References: