This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
304
Orasis Investigative Site
Chandler, Arizona, United States
Orasis Investigative Site
Mesa, Arizona, United States
Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Time frame: Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (2 hours post-Dose 1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1)
Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
Time frame: Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1)
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Orasis Investigative Site
Phoenix, Arizona, United States
Orasis Investigative Site
Garden Grove, California, United States
Orasis Investigative Site
Mission Hills, California, United States
Orasis Investigative Site
Newport Beach, California, United States
Orasis Investigative Site
Petaluma, California, United States
Orasis Investigative Site
Littleton, Colorado, United States
Orasis Investigative Site
Danbury, Connecticut, United States
Orasis Investigative Site
Delray Beach, Florida, United States
...and 8 more locations