Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A multicenter, randomized, double-Blind, crossover, placebo-controlled Phase II clinical Study to evaluate the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF in the treatment of Chinese patients with presbyopia.
Eligibility Criteria
Inclusion Criteria: 1. At Visit 1 (Screening Period), the age ranges from 45 to 75 years old, regardless of gender 2. At Visit 1 (Screening Period), the corrected distance visual acuity of either eye is ≥ 0.8 (National Standard Logarithmic Visual Acuity Scale,decimal visual acuity) in the clinical routine manifest refraction (distance vision). 3. At Visit 1 (Screening Period), the manifest refraction (distance vision under mesopic conditions) results are as follows: For any eye,-4.00D ≤ equivalent spherical lens power ≤ +2.00D, and the negative cylinder lens power is ≥-2.00D; 4. At least one eye meeting the following at both Visit 1 and Visit 2: 1. Under mesopic conditions, monocular corrected near visual acuity (MCNVA) ≤65 ETDRS letters (equivalent to decimal visual acuity 0.4) ; 2. Under mesopic conditions, monocular corrected near visual acuity with a multiple-pinhole occluder (MCNVA\_P) improves by ≥15 ETDRS letters compared to monocular corrected near visual acuity without the occ