Efficacy and safety of pilocarpine hydrochloride ophthalmic solution USP 1.25% w/v versus placebo ophthalmic solution for the treatment of presbyopia - A multicentric clinical trial.

ABSTRACT:

Purpose

To evaluate the efficacy and safety of 1.25% pilocarpine compared to placebo for the treatment of presbyopia.

Methods

This multicenter, randomized, double-masked clinical trial compared pilocarpine 1.25% to placebo in presbyopic individuals aged 45-55 years, meeting standard near vision impairment criteria. Participants were randomized 1:1 using a computer-generated sequence, with identical, unmarked bottles ensuring masking. Distance-corrected near visual acuity (DCNVA) and distance-corrected intermediate visual acuity (DCIVA) were assessed under mesopic and photopic conditions across multiple visits (days 1, 3, 7, 14, and 30). The primary outcome was a ≥ 3-line gain in mesopic, high-contrast, binocular DCNVA at day 30, hour 3. Secondary outcomes included photopic a

SUBMITTER: Singh P 

PROVIDER: S-EPMC12448526 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature