Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
- Conditions
- Presbyopia
- Interventions
- Other: Vehicle
- Registration Number
- NCT03804268
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
- Subjective complaints of poor near vision that impact activities of daily living
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Participants received one drop of vehicle in each eye, once daily, for up to 30 days. 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 Baseline (Day 1) to Day 30 (Hour 3) Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 Baseline (Day1) to Day 30 (Hour 10) Visual acuity for near (40cm) 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.
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. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.
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 an article in newspaper, 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, rating their vision-related reading ability 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 on performance 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).
Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (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 candelas per square meter 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) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported.
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 low lighting 3.2 to 3.5 cd/m\^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. Mixed effect model for repeated measures (MMRM) was used for analyses.
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. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.
Mean Change From Baseline in Presbyopia Impact and 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.
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. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses.
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) target was measured in mesopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported.
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. PICQ Impact domain had 6 items: Item 9:Rely on others,15:rest eyes,16:Feel older,17:Feel self-conscious,19:Take longer to complete a task,20:Inconvenient. First 5 impacts items included response categories: 0=never to 4=all the time. Item 20 had response categories: 0=not at all to 4=extremely. Item 9 included an additional response category with a value of 9 to indicate question was not applicable to participant and the responses were assigned missing values. PICQ Impacts Score=\[(Item9+Item15+Items16,17Testlet+Item19+Item20)/(nonmissing responses to 5 components of impacts score)\] where Items 16,17 Testlet=(Item16+Item17)/non-missing responses to Items 16 and 17. PICQ Impact score ranges from 0 to 4; with 0=least amount of impacts to 4=greatest amount of impacts. Higher scores correspond to poorer outcomes. A negative change from Baseline=improvement.
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 an article in newspaper, 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, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close to 5=excellent; impact of squinting on performance 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,1=dissatisfied,2=neither satisfied nor dissatisfied,3=satisfied, 4=very satisfied. The score based on satisfaction items=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses) for a total possible score of 0 to 4. Higher scores=better outcomes; a positive change from Baseline=higher satisfaction.
Trial Locations
- Locations (36)
American Institute of Research
🇺🇸Los Angeles, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Danbury Eye Physicians and Surgeons P.C.
🇺🇸Danbury, Connecticut, United States
Bruce Segal, MD
🇺🇸Delray Beach, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Key-Whitman Eye Center
🇺🇸Dallas, Texas, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States
Haas Vision Center
🇺🇸Colorado Springs, Colorado, United States
Assil Eye Institute
🇺🇸Beverly Hills, California, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Sabates Eye Centers
🇺🇸Leawood, Kansas, United States
Schwartz Laser Eye Center
🇺🇸Scottsdale, Arizona, United States
The Eye Associates
🇺🇸Bradenton, Florida, United States
Seidenberg Protzko Eye Associates
🇺🇸Havre De Grace, Maryland, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Hoopes, Durrie, Rivera Research
🇺🇸Draper, Utah, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Alterman, Modi & Wolter
🇺🇸Poughkeepsie, New York, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Mundorf Eye Center
🇺🇸Charlotte, North Carolina, United States
EyeCare Professionals DWA Insight Research Clinic, LLC
🇺🇸Powell, Ohio, United States
PNV Clinical Research LLC
🇺🇸San Antonio, Texas, United States
Southern College of Optometry
🇺🇸Memphis, Tennessee, United States
Hill Country Eye Center
🇺🇸Cedar Park, Texas, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Grutzmacher & Lewis, A Medical Corporation DBA Sacramento Eye Consultants
🇺🇸Sacramento, California, United States
USF Eye Institute
🇺🇸Tampa, Florida, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
Nashville Vision Associates
🇺🇸Nashville, Tennessee, United States