A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solution
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Best-corrected distance visual acuity (BCDVA) at 40 cm
Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m)
Time frame: 3 hours post-treatment in the study eye at Visit 2 (Day 1)
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Peking University First Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Ineye Hospital of Chengdu University of TCM
Chengdu, China
Dalian N0.3 people's hospital
Dalian, China
Guang Zhou Aier eye Hospital
Guangzhou, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
Jinan, China
...and 9 more locations