Pilocarpine hydrochloride 4% eye drops preservative free

This study systematically evaluates the efficacy, safety, tolerability, and contemporary clinical positioning of topical pilocarpine in the management of glaucoma and ocular hypertension. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. PubMed/MEDLINE, EMBASE, Cochrane CENTRAL via the Cochrane Library, Scopus, Web of Science Core Collection, and Google Scholar were searched from inception to 1 May 2026 without language restrictions. Randomized controlled trials and controlled observational studies in adults with glaucoma or ocular hypertension were eligible when topical pilocarpine, used alone or in combination, was compared with placebo, no treatment, laser trabeculoplasty, or other intraocular pressure (IOP)-lowering therapies. The primary outcome was mean change in IOP, and secondary outcomes included responder outcomes, ocular adverse events, discontinuation, visual field outcomes, medication burden, post-laser pressure spikes, and postoperative outcomes. Risk of bias was assessed with the Cochrane Risk of Bias 2.0 tool (RoB 2.0) for randomized studies and the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool for nonrandomized studies. We performed random-effects meta-analysis using raw mean difference in mmHg for continuous outcomes and risk ratio (RR) for binary safety outcomes, each reported with a 95% confidence interval (CI); certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Of the 38 studies that met the inclusion criteria, 34 contributed data to the quantitative meta-analysis. In the primary analysis, pilocarpine-containing regimens reduced IOP by an additional 1.16 mmHg compared to all comparators (95% CI 0.84 to 1.47; P 2 = 50.7%). Subgroup analyses suggested larger pooled effects in placebo/no-treatment comparisons, ocular hypertension, primary open-angle glaucoma, and monotherapy studies; however, comparisons with beta-blockers and prostaglandin analogs require cautious interpretation because several large individual trials favored timolol or latanoprost for daily clinical use, tolerability, or dosing convenience. Pilocarpine was associated with a sevenfold higher risk of blurred vision (RR 7.33; 95% CI 3.30 to 16.29) and a sixfold higher risk of discontinuation due to adverse events (RR 6.07; 95% CI 3.69 to 10.00). Egger's test pointed to funnel plot asymmetry (P = 0.003), although the trim and fill method did not impute any missing studies. Pilocarpine lowers IOP effectively, but its modern role is limited by frequent dosing, miosis, blurred vision, accommodative symptoms, brow ache, and higher discontinuation. In current glaucoma care, prostaglandin analogs and selective laser trabeculoplasty are generally more consistent with first-line open-angle glaucoma management, whereas pilocarpine is better positioned for selected clinical scenarios, including angle-closure mechanisms, post-laser pressure-spike prophylaxis, selected postoperative angle-surgery settings, intolerance or nonresponse to other drug classes, and resource-limited settings where newer therapies are unavailable or unaffordable.

Abstract licence: CC BY

Pilocarpine, the first Food and Drug Administration-approved ophthalmic solution for presbyopia treatment, has garnered substantial attention owing to its therapeutic efficacy and safety profile. This meta-analysis systematically evaluated the effectiveness and safety of pilocarpine in managing presbyopia.Relevant literature published before April 1, 2025 can be retrieved from Web of Science, Embase, PubMed, and Cochrane Library. After screening, extract baseline features and outcome data for inclusion in the study. Finally, a meta-analysis and Trial Sequential Analysis (TSA) were conducted.Five randomized controlled trials (RCTs) were included in this meta-analysis. The meta-analysis demonstrated that pilocarpine significantly increased the number of participants who achieved a mesopic distance-corrected near visual acuity (DCNVA) gain of ≥ 3 lines at 1 h (relative risk [RR]: 1.99, 95% confidence interval [CI] 1.55-2.56), 2 h (RR: 2.08, 95% CI 1.61-2.69), 3 h (RR: 4.30, 95% CI 2.84-6.52), 6 h (RR: 2.02, 95% CI 1.59-2.56), and 8 h (RR: 1.77, 95% CI 1.37-2.28), compared to controls. However, pilocarpine significantly increased the risk of participants experiencing ≥ 1 treatment-emergent adverse events (TEAEs), blurred vision, visual impairment, eye pain, headache, and nausea (P  0.05). TSA revealed conclusive results for mesopic DCNVA gain of ≥ 3 lines, participants with ≥ 1 TEAEs, blurred vision, visual impairment, and nausea. Except for eye pain (P = 0.010), the remaining outcomes showed no potential publication bias (P > 0.05). The evidence quality for DCNVA gain of ≥ 3 lines was rated as moderate, while that for safety outcomes ranged from very low to moderate.In conclusion, pilocarpine improves visual function in patients with presbyopia; however, it may increase the risk of adverse events. Owing to the limited sample size, these findings warrant further validation through large-scale multicenter RCTs.

Abstract licence: CC BY-NC-ND