{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T14:24:33Z","timestamp":1787840673401,"version":"build-2784847793"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","license":[{"start":{"date-parts":[[2025,8,29]],"date-time":"2025-08-29T00:00:00Z","timestamp":1756425600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,9]]},"abstract":"\n Purpose:<\/jats:title>\n To evaluate the efficacy and safety of 1.25% pilocarpine compared to placebo for the treatment of presbyopia.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n This multicenter, randomized, double-masked clinical trial compared pilocarpine 1.25% to placebo in presbyopic individuals aged 45\u201355 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 \u2265 3-line gain in mesopic, high-contrast, binocular DCNVA at day 30, hour 3. Secondary outcomes included photopic and intermediate vision improvements.<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n A total of 234 participants (mean age 49 \u00b1 3 years, 57% male) were randomized equally. By day 3, pilocarpine demonstrated a significant half-line improvement in high-contrast, binocular mesopic DCNVA (0.47 \u00b1 0.1 vs. 0.51 \u00b1 0.1 logMAR,\n P<\/jats:italic>\n = 0.03), progressing to 1.3 lines by day 30 (0.37 \u00b1 0.1 vs. 0.50 \u00b1 0.1,\n P<\/jats:italic>\n < 0.001). Nearly 50% achieved a two-line gain (n = 54 [46%] vs. 10 [8%],\n P<\/jats:italic>\n = 0.001), and one-third gained three lines (n = 36 [31%)] vs. 5 [4%],\n P<\/jats:italic>\n < 0.001). Pilocarpine\u2019s effect was cumulative, with each visit\u2019s baseline DCNVA surpassing prior measurements (\n P<\/jats:italic>\n < 0.001). Photopic DCNVA followed a similar trend (0.31 \u00b1 0.1 vs. 0.43 \u00b1 0.1 logMAR,\n P<\/jats:italic>\n = 0.02 at day 30, hour 3). Intermediate DCIVA showed a modest half-line improvement by day 30. No adverse drug reactions or ophthalmic side effects were observed during the study.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n Pilocarpine 1.25% effectively improves near vision in presbyopia, with sustained benefits up to day 30 and potential long-term adaptability.<\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijo.ijo_680_25","type":"journal-article","created":{"date-parts":[[2025,8,29]],"date-time":"2025-08-29T16:02:00Z","timestamp":1756483320000},"page":"1251-1257","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of pilocarpine hydrochloride ophthalmic solution USP 1.25% w\/v versus placebo ophthalmic solution for the treatment of presbyopia \u2013 A multicentric clinical trial"],"prefix":"10.4103","volume":"73","author":[{"given":"Parul","family":"Singh","sequence":"first","affiliation":[{"name":"Department of Ophthalmology (DOP), GSVM Hospital, Kanpur, Uttar Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tejal","family":"Garasiya","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology (DOP), Anand Multispeciality Hospital and Research Centre, Gandhinagar, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidya","family":"Ajila","sequence":"additional","affiliation":[{"name":"Regulatory Affairs, Entod Pharmaceuticals Ltd, Mumbai, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabyasachi","family":"Sengupta","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology (DOP) Future Vision Eye Care, Mumbai, Maharashtra, India"},{"name":"Department of Ophthalmology (DOP), National Institute of Ophthalmology, Pune, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditi","family":"Datta","sequence":"additional","affiliation":[{"name":"CEO, Biosite Research Private Limited, Bengaluru, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Nivean","sequence":"additional","affiliation":[{"name":"Department of Cataract and Vitreoretinal Services M. N Eye Hospital, Chennai, Tamil Nadu, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,8,29]]},"reference":[{"key":"R1-20260420","doi-asserted-by":"crossref","first-page":"863","DOI":"10.1016\/S0161-6420(99)00502-3","article-title":"The mechanism of accommodation in primates","volume":"106","author":"Glasser","year":"1999","journal-title":"Ophthalmology"},{"key":"R2-20260420","doi-asserted-by":"crossref","first-page":"1723","DOI":"10.1007\/s40123-024-00935-w","article-title":"Understanding perspectives on presbyopia and use of pilocarpine HCl 1.25% twice daily from participants of the phase 3 VIRGO study","volume":"13","author":"Shafer","year":"2024","journal-title":"Ophthalmol Ther"},{"key":"R3-20260420","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1016\/j.clinthera.2023.12.005","article-title":"Efficacy and safety of CSF-1 (0.4% pilocarpine hydrochloride) in presbyopia: Pooled results of the NEAR phase 3 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