Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
Vehicle ophthalmic solution administered with the Optejet microdose dispenser
VISION-1 Study Site #21
Azusa, California, United States
VISION-1 Study Site #52
Newport Beach, California, United States
VISION-1 Study Site #54
Fort Collins, Colorado, United States
VISION-1 Study Site #53
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
Time frame: 120 minutes post-dosing
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Orlando, Florida, United States
VISION-1 Study Site #50
New York, New York, United States
VISION-1 Study Site #17
High Point, North Carolina, United States
VISION-1 Study Site #22
Raleigh, North Carolina, United States
VISION-1 Study Site #51
Cranberry Township, Pennsylvania, United States
VISION-1 Study Site #03
San Antonio, Texas, United States