A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
- Conditions
- Presbyopia
- Interventions
- Drug: Pilocarpine HCl Ophthalmic SolutionOther: Vehicle
- Registration Number
- NCT03857542
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 427
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pilocarpine HCl Ophthalmic Solution Pilocarpine HCl Ophthalmic Solution Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days. Vehicle Vehicle Participants received one drop of vehicle in each eye, once daily, for up to 30 days.
- Primary Outcome Measures
Name Time Method 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 Baseline (Day 1) to Day 30 (Hour 3) Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid identified (as applicable) were recorded. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. DCNVA= distance-corrected near visual acuity.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 Baseline (Day 1) to Day 30 (Hour 0.5) Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as lighting 3.2 to 3.5 cd/m\^2 measured at the target. Mixed effect model for repeated measures (MMRM) was used for the analysis.
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA at Day 30, Hour 6 Baseline (Day 1) to Day 30 (Hour 6) Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 Baseline (Day 1) to Day 30 (Hour 8) Visual acuity for near (40 cm) was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. Baseline for efficacy was defined as the last non-missing efficacy assessment before the first dose of study intervention. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular DCNVA at Day 30, Hour 1 Day 30 (Hour 1) Visual acuity for near (40 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target.
Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from a newspaper article, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rated as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent; impact of squinting as 0=No,I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes,but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. The score based on vision-related ability and impact of squinting=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses), total possible score of 0-5. Higher scores=better outcomes;positive change from Baseline=improved performance (reading ability).
Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) Visual acuity for intermediate (66 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target. MMRM was used for the analysis.
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 Baseline (Day 1) to Day 30 (Hour 10) Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported.
Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25 Baseline (Day 1) to Day 30 (Hour 0.25) Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. MMRM was used for the analysis.
Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3 Day 30 (Hour 3) Visual acuity for near (40 cm) targets was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target.
Mean Change From Baseline in Mesopic NVPTQ Satisfaction Score at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from a newspaper article, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, related as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent; impact of squinting as 0=No, I did not squint, 1=Yes, squinting helped me read some/all text, 2=Yes, but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. NVPTQ Satisfaction Score=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses)based on satisfaction items for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline indicates higher satisfaction.
Mean Change From Baseline in Presbyopia Coping Questionnaire (PICQ) Coping Score at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) PICQ=20 questions about impact experienced by participants due to their problems over past 7 days.PICQ Coping domain had 8 items: 1:Normal-sized text,2:Small-sized text,3:Information on a computer,4:Information on a cell phone,5:Increase font size,6:Use glasses to read close,12:Hold reading materials farther out/closer,13:Squint to read. Each item had response categories:0=never to 4=all the time. Items 3, 4, 5, and 6 had additional response categories with values of 9/10 to indicate the question is not applicable to participant and were assigned missing values.PICQ Coping Score:(Item 1,2 Testlet+Item 3,4 Testlet+Item 5+Item 6+Item 12+Item 13)/non-missing responses to the 6 components of coping score where Items 1,2 Testlet=(Item1+Item2)/non-missing responses to Items 1,2;Items 3,4 Testlet=(Item3+Item4)/non-missing responses to Items 3, 4. Score ranges:0=to least amount of coping to 4=greatest amount of coping. Higher scores=poorer outcome; a negative change from Baseline=improvement.
Mean Change From Baseline in PICQ Impact Score at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) PICQ had 20 questions about impact experienced by participants due to their problems seeing up over past 7 days. Impact domain of PICQ has 6 items:Item9:Rely on others,Item15:rest eyes,Item16:Feel older,Item17:Feel self-conscious,Item19:Take longer to complete task,Item20:Inconvenient.First 5 impacts items include response ranges from 0=never to 4=all of time. Item20 ranged from 0=Not at all,to 4=Extremely. Item9 included an additional response category, labeled with value of 9 to indicate question is not applicable because participant did not have opportunity to experience impact responses are assigned missing values. PICQ Impacts Score=\[(Items 9+15+16\&17 Testlet+Item19+Item20)/(nonmissing responses to 5 components of impacts score)\] where Items 16\&17 Testlet=(Items16+17)/non-missing responses to Items16 and 17. PICQ Impact score ranged 0-4, 0=least amount of impacts,4=greatest amount of impacts. Higher scores correspond to poorer outcomes; negative change from Baseline=improvement.
Trial Locations
- Locations (35)
Advanced Vision Care
🇺🇸Los Angeles, California, United States
South Florida Vision Center
🇺🇸Fort Lauderdale, Florida, United States
Eye Center South
🇺🇸Dothan, Alabama, United States
M&M Eye Institute
🇺🇸Prescott, Arizona, United States
Walman Eye Center
🇺🇸Sun City, Arizona, United States
Milton M. Hom, OD, FAAO
🇺🇸Azusa, California, United States
Mid Florida Eye Center
🇺🇸Mount Dora, Florida, United States
Newsom Eye & Laser Center
🇺🇸Sebring, Florida, United States
Cincinnati Eye Institute
🇺🇸Edgewood, Kentucky, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Keystone Research ltd. at Texan Eye
🇺🇸Austin, Texas, United States
The Cataract and Glaucoma Center
🇺🇸El Paso, Texas, United States
Texas Eye & Laser Ctr
🇺🇸Hurst, Texas, United States
Benjamin Travis Dastrup, MD
🇺🇸Ogden, Utah, United States
North Valley Eye Medical Group, Inc.
🇺🇸Mission Hills, California, United States
Global Research Management
🇺🇸Glendale, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Corneal Consultants of Colorado
🇺🇸Littleton, Colorado, United States
Benjamin Knox Lambright, MD
🇺🇸Crystal River, Florida, United States
Clayton Eye Center
🇺🇸Morrow, Georgia, United States
The Midwest Center for Sight
🇺🇸Des Plaines, Illinois, United States
Jacksoneye
🇺🇸Lake Villa, Illinois, United States
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Heart of America Eyecare
🇺🇸Shawnee Mission, Kansas, United States
Chu Laser Eye Institute
🇺🇸Bloomington, Minnesota, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Amel Youssef, OD
🇺🇸Las Vegas, Nevada, United States
Bucci Laser Vision
🇺🇸Wilkes-Barre, Pennsylvania, United States
Debry Medical Services PC
🇺🇸Las Vegas, Nevada, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
University Eye Surgeons
🇺🇸Maryville, Tennessee, United States
Waring Vision Institute
🇺🇸Mount Pleasant, South Carolina, United States
Bowden Eye Associates
🇺🇸Jacksonville, Florida, United States
Vision Consultants and Surgeons
🇺🇸Falls Church, Virginia, United States