Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.
Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
469
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
LNZ100 Aceclidine ophthalmic solution
Brimonidine ophthalmic solution
Site #106
Chandler, Arizona, United States
Site #121
Mesa, Arizona, United States
Primary Outcome
Efficacy Study of the percentage of subjects who achieve a 3-line or greater improvement from baseline in the study eye with no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m).
Time frame: 3 hours post-treatment in the study eye
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Site #122
Phoenix, Arizona, United States
Site #124
Phoenix, Arizona, United States
Site #125
Sun City, Arizona, United States
Site #110
Garden Grove, California, United States
Site #101
Glendale, California, United States
Site #107
Petaluma, California, United States
Site #126
Rancho Cordova, California, United States
Site #111
Santa Barbara, California, United States
...and 10 more locations