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<p>The study aimed to evaluate the safety and effect of various dosages of topical neostigmine ophthalmic solution (TNOS) in animal models and establish a recommended dosage for further studies on myasthenia gravis (MG) diagnosis. A placebo-controlled, sequential ascending dose study was conducted in healthy rabbits. Eighteen eyes were randomized to receive one of three concentrations (1.0, 1.5, and 2.5&#xa0;mg/mL) of TNOS. Pupillary sizes over time were compared with control group that received normal saline solution (NSS). Mean pupillary size of the 1.5&#xa0;mg/mL group was significantly smaller than control at 30 to 180&#xa0;min after instillation (maximal mean difference (TNOS - NSS); mMD − 2.58, 95% confidence interval (95% CI) -4.24 to -0.93, <i>p</i> = 0.006). The mean pupillary size of the 2.5&#xa0;mg/mL group was significantly smaller than the control at 60 to 90&#xa0;min (mMD − 3.13, 95% CI -5.07 to -1.18, <i>p</i> = 0.005). No significant difference in pupillary size between 1.5 and 2.5&#xa0;mg/mL groups was observed at any time points. No systemic or ocular complications were observed in any concentration. The 1.5&#xa0;mg/mL TNOS was the lowest efficacious dose in this study without adverse effects and was considered a promising starting dose for further MG studies.</p>

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Safety and effect of topical neostigmine ophthalmic solution in animal models

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月22日

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  • Chuthamas Ongprakobkul,
  • Supharat Jariyakosol,
  • Supanut Apinyawasisuk,
  • Kasem Rattanapinyopituk,
  • Pajaree Chariyavilaskul,
  • Kornvalee Meesilpavikkai,
  • Yuda Chongpison

摘要

The study aimed to evaluate the safety and effect of various dosages of topical neostigmine ophthalmic solution (TNOS) in animal models and establish a recommended dosage for further studies on myasthenia gravis (MG) diagnosis. A placebo-controlled, sequential ascending dose study was conducted in healthy rabbits. Eighteen eyes were randomized to receive one of three concentrations (1.0, 1.5, and 2.5 mg/mL) of TNOS. Pupillary sizes over time were compared with control group that received normal saline solution (NSS). Mean pupillary size of the 1.5 mg/mL group was significantly smaller than control at 30 to 180 min after instillation (maximal mean difference (TNOS - NSS); mMD − 2.58, 95% confidence interval (95% CI) -4.24 to -0.93, p = 0.006). The mean pupillary size of the 2.5 mg/mL group was significantly smaller than the control at 60 to 90 min (mMD − 3.13, 95% CI -5.07 to -1.18, p = 0.005). No significant difference in pupillary size between 1.5 and 2.5 mg/mL groups was observed at any time points. No systemic or ocular complications were observed in any concentration. The 1.5 mg/mL TNOS was the lowest efficacious dose in this study without adverse effects and was considered a promising starting dose for further MG studies.